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Johnson & Johnson Vision
Johnson & Johnson Vision
from Wikipedia

Johnson & Johnson Vision (JJV) is a subsidiary of Johnson & Johnson and is composed of two divisions, Johnson & Johnson Surgical Vision and Johnson & Johnson Vision Care (Contact Lens).[1] The company is part of Johnson & Johnson MedTech business segment.[2] Services include Intraocular lenses, laser vision correction systems, phacoemulsification systems, viscoelastic, Microkeratomes and related products used in cataract and refractive surgery.

Key Information

Johnson and Johnson Surgical Vision is based in Santa Ana, California, and Johnson & Johnson Vision Care is based in Jacksonville, Florida. JJV employs approximately 4,200 worldwide. The company has operations in 24 countries and markets products in approximately 60 countries. In February 2017, Abbott Medical Optics changed its name to Johnson & Johnson Vision following its $4.3 billion acquisition by Johnson & Johnson.

History

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In 1959, the contact business unit started as Frontier Contact Lenses in Buffalo, New York.[3]

The surgical business unit started when implantable medical device company Heyer-Schulte Co., started a ophthalmic research division, named Heyer-Schulte Medical Optics Center (HSMOC), focusing on aphakic lenses and extended-wear cosmetic contact lenses.  In 1974, American Hospital Supply Corporation (AHSC), acquired and merged with Heyer-Schulte Co., and renamed HSMOC to American Medical Optics (AMO).[4] In 1976, AMO focused its business in the early development of intraocular lenses for cataract patients.

In 1981, Johnson & Johnson acquires Frontier.[3]

In 1983, American Medical Optics, the Santa Ana eye product division of American Hospital Supply Corp., began to manufacture the tissue lens.[citation needed]

In 1986, Allergan acquired American Medical Optics, and as Allergan Medical Optics, continued to manufacture the lenticules.

In 1987, JJV introduces the world’s first disposable soft contact lenses under the name ACUVUE Brand Contact Lenses.[3]

AMO was spun off from Allergan in 2002.[5]

In 2004, Advanced Medical Optics bought Pfizer’s surgical ophthalmology business for $450 million in cash.[6]

AMO acquired VisX Inc. in a stock and cash transaction valued at approximately $1.27 billion, in November 2004. The combined company retained the Advanced Medical Optics name and AMO's Santa Ana, Calif., headquarters. The laser franchise retained the VisX brand name, and VisX continued manufacturing and research and development activities at its Santa Clara, Calif., site. The AMO portfolio already included the Amadeus II microkeratome, the Verisyse phakic IOL, and the ReZoom, Array and Tecnis IOLs.

In Jan. 16, 2007 AMO announced the acquisition of privately held WaveFront Sciences Inc., a provider of wavefront diagnostic systems for refractive surgery and medical research, for $20 million in cash.[7]

AMO acquired Irvine-based IntraLase Corp. for $808 million in January 2007.[8] This allowed AMO to combine IntraLase technology for cutting a flap in the cornea with AMO technology for reshaping the cornea. The combination of these complementary technologies has made "all-laser LASIK" possible.[9] NASA later approved this all-laser LASIK for use on astronauts.[10]

In August 2007 the company donated $2.5 million to UC-Irvine's Department of Ophthalmology to boost the university's planned Eye Institute.[10]

On February 26, 2009, Abbott Laboratories announced that it had completed its acquisition of Advanced Medical Optics (AMO) in a $2.8 billion deal. AMO had become a wholly owned subsidiary of Abbott and was renamed Abbott Medical Optics Inc (AMO).

In 2009, AMO bought Visiogen and 2013, OptiMedica.[11][12]

In September 2016, pharmaceutical and medical device company Johnson & Johnson announced they were buying Abbott Medical Optics for $4.3 billion.[13]

On February 27, 2017, Abbott Medical Optics changed its name to Johnson & Johnson Vision following its $4.3 billion acquisition by Johnson & Johnson.[14]

In 2017, JJV acquired TearScience.[15]

Products

[edit]
  • Corneal products:
    • RevitaLens OcuTec Multi-Purpose Disinfecting Solution
    • COMPLETE Multi-Purpose Solution Easy Rub Formula
    • Blink Tears Lubricating Eye Drops
    • Oxysept UltraCare Formula Peroxide Disinfection System
    • Ultrazyme Enzymatic Cleaner
    • Blink Contacts Lubricating Eye Drops
    • COMPLETEBlink-N-Clean Lens Drops
    • COMPLETE Lubricating and Rewetting Drops
  • Refractive Products (LASIK)
    • STAR S4 IR Excimer Laser
    • WaveScan WaveFront System
    • IntraLase FS Laser
    • Advanced CustomVue Procedure
    • iFS Advanced Femtosecond Laser
  • Cataract Products
    • Tecnis Multifocal Intraocular lens
    • ReZoom Multifocal Intraocular lens
    • Tecnis 1-Piece Intraocular lens
    • WHITESTAR Signature Phacoemulsification System
    • Sovereign Compact Phacoemulsification System
    • Healon Viscoelastics
    • Baerveldt Glaucoma Implants
    • StabilEyes Capsular Tension Ring
    • Catalys Precision Laser System

Voluntary recalls

[edit]

AMO voluntarily recalled some of their products in 2006 due to a bacterial contamination in the factory process which would have compromised sterility. Non-sterility of a contact lens solution may have serious health consequences, including eye infection and microbial keratitis.[citation needed] The voluntary and limited recall was caused by an isolated production line problem that affected two of the four production lines in the AMO facility, not because of a formulation issue.[16]

In May 2007, the Centers for Disease Control and Prevention linked AMO MoisturePlus eye solution to Acanthamoeba keratitis infections.[17] AMO announced a recall on Complete MoisturePlus contact lens solution on May 28, 2007.[18] The solution has been linked to cases of an eye infection (keratitis) caused by an organism of the genus Acanthamoeba.[19] The company was sued in June 2007 by Michael Connolly, who claimed to have developed a keratitis infection after using AMO's MoisturePlus solution.[20][21]

Complaints about a contact lens solution linked to a 2007 outbreak of eye infections that blinded several people went unreported by the manufacturer for more than a year. Advanced Medical Optics received complaints about the solution more than a year before it was recalled, and failed to promptly report nine complaints as required by law.[22]

References

[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia
from Grokipedia
Vision is a division of MedTech dedicated to addressing global vision needs through innovative eye care products and surgical solutions, serving over 44 million people annually. The division focuses on tackling major eye health challenges, including the global epidemic of affecting more than 2 billion people, with 1 billion cases preventable or unaddressed, and projections of a 50% increase by 2030. It offers a range of consumer and professional products, such as the ACUVUE® brand of prescription contact lenses designed for conditions like (affecting over 2 billion people globally as of 2020), (over 1 billion), and (about 1 in 3 people). Surgical innovations include intraocular lenses for treatment—the leading cause of blindness in most countries among adults over 40—and vision correction procedures like iLASIK, alongside therapies for dry eye disease, particularly impacting over 340 million worldwide. As part of MedTech's portfolio, which emphasizes precision technologies for complex health issues, the Vision segment plays a strategic role in advancing less invasive, personalized eye care to improve at every stage.

Company Overview

Formation and Scope

Johnson & Johnson Vision was formally established in 2017 following Johnson & Johnson's $4.325 billion acquisition of Abbott Medical Optics (AMO), a leading eye care company, which was subsequently rebranded and integrated with the parent company's existing vision care operations. This move consolidated expertise in , creating a unified entity dedicated to eye health. The division's roots in vision care trace back to the , with the establishment of Vistakon in 1981 and the launch of the ACUVUE® brand of contact lenses in 1987. As part of Johnson & Johnson's MedTech segment, Johnson & Johnson Vision specializes in comprehensive eye health solutions, encompassing contact lenses for vision correction, intraocular lenses (IOLs) for , and technologies for . Headquartered in , the company operates a global network with manufacturing facilities spanning the , , and to support production and distribution. Employing between 5,000 and 10,000 people worldwide as of 2025, it contributes around $5 billion in annual revenue to the parent corporation in recent years, reflecting its significant scale within the MedTech portfolio. Vision sales reached $5.1 billion in 2024, with operational growth continuing into 2025 (7.7% in Q3). The core mission of Johnson & Johnson Vision centers on advancing vision care innovation to combat prevalent conditions such as refractive errors, cataracts, and dry eye, serving over 44 million people annually and addressing the global burden of visual impairment affecting more than 2 billion individuals. By prioritizing in sustainable eye health technologies, the division aims to prevent and treat vision loss, fostering a healthier future amid rising projections of a 50% increase in by 2030.

Leadership and Global Operations

Johnson & Johnson Vision is led by Company Group Chairman Peter Menziuso, who has over 30 years of experience within the company and oversees the full portfolio encompassing contact lenses, surgical vision solutions, and consumer eye care products. In August 2025, Caroline Blackie was appointed Vice President of Medical Affairs, Vision, and Paul Lisenby as Global Head of , Vision. Key executives include Shawn Millerick as President of Vision Care, Americas, responsible for strategy and growth in North and . As part of Johnson & Johnson's MedTech sector, the division reports to the company's Executive Committee, with direct oversight from Tim Schmid, Executive Vice President and Worldwide Chairman of MedTech, and ultimate governance from Chairman and CEO . The organizational structure integrates seamlessly into Johnson & Johnson's decentralized model, enabling agile decision-making while leveraging corporate resources for global scaling. Dedicated R&D centers in —home to the global headquarters for Vision Care—and , , focus on innovation in materials, surgical optics, and eye health diagnostics. Johnson & Johnson Vision maintains a robust global footprint, with operations supporting distribution in more than 60 countries and serving over 44 million patients annually. In 2024, the division generated $5.1 billion in sales, with approximately 41% from the and 59% from international markets, including strong contributions from (23% of overall company sales) and / (15%). Key subsidiaries, such as Johnson & Johnson Vision Care, Inc., drive these efforts by managing regional subsidiaries and adapting products to local regulatory and cultural needs. The supply chain emphasizes efficiency and resilience, with major manufacturing facilities in Jacksonville, Florida, and Limerick, Ireland, producing over 1.7 billion contact lenses annually to meet worldwide demand. Sustainability initiatives are integral, including the introduction of 100% sustainable paper packaging—certified by the Forest Stewardship Council—for all ACUVUE® contact lenses, along with a recycling program that processed over 11 million items, including packaging, in 2023. Strategic partnerships enhance operations and education, such as collaborations with the American Optometric Association (AOA) on patient safety initiatives and the Association for School and College Optometry (ASCO) to promote diversity and eye health awareness in professional training.

Historical Development

Origins and Early Innovations

Johnson & Johnson Vision's roots in contact lens technology trace back to 1959, when Frontier Contact Lenses was founded in , initially focusing on the production of rigid gas-permeable lenses. By the late 1970s, the company expanded into soft contact lenses, capitalizing on the material's comfort advantages over earlier rigid designs, and established a manufacturing facility in . This shift positioned Frontier as a key player in the emerging soft lens market, which had been pioneered industry-wide in the early through innovations but gained commercial traction in the following decade. In 1981, acquired Frontier, rebranding it as Vistakon and accelerating investments in soft lens technology. Under Vistakon, the company introduced extended-wear contact lenses in 1987 with the launch of the ACUVUE brand, enabling overnight use for up to seven days and addressing a major need for patients requiring continuous vision correction, such as those post-cataract surgery. These innovations built on hydrogel formulations like etafilcon A, developed in the , to improve oxygen permeability and wearer comfort while reducing risks associated with prolonged wear. By the mid-1980s, Vistakon's advancements in manufacturing processes, including stabilized soft molding techniques acquired from European partners, enhanced production efficiency and lens quality. Parallel to the contact lens developments, the surgical vision segment originated with Heyer-Schulte Medical Optics, established in the early as a pioneer in ophthalmic implants and medical optics. The company contributed to early (IOL) in the 1970s, producing some of the first FDA-approved IOLs for . In 1974, American Hospital Supply Corporation acquired Heyer-Schulte, renaming its optics division American Medical Optics (AMO) and integrating it into broader ophthalmic efforts focused on refractive and corneal procedures. Key milestones in the and solidified these foundations. In 1987, Vistakon launched the ACUVUE brand, introducing the world's first frequent-replacement soft with a biweekly schedule, which revolutionized hygiene practices and boosted adoption rates among consumers. On the surgical front, AMO expanded its IOL portfolio in the through strategic acquisitions. acquired Iolab Corporation in 1980, which brought advanced IOL designs and strengthened market leadership in solutions. These moves emphasized innovations in corneal and , such as foldable IOLs that minimized incision sizes during procedures. The 2000s brought further growth amid industry consolidation. In 2002, spun off AMO as an independent company, allowing focused expansion in refractive technologies like wavefront-guided systems. AMO's revenues grew steadily, reaching approximately $1 billion by 2010, driven by demand for premium IOLs and surgical consumables. By 2016, ahead of its acquisition by , AMO's annual sales had climbed to around $1.1 billion, reflecting robust performance in global markets despite competitive pressures in . This period highlighted Vistakon's and AMO's complementary strengths, setting the stage for their 2017 integration into a unified vision care entity.

Acquisition by Johnson & Johnson

In September 2016, Johnson & Johnson announced a definitive agreement to acquire Abbott Medical Optics (AMO), a leading provider of surgical and consumer eye care products, for $4.325 billion in an all-cash transaction. The deal was completed on February 27, 2017, following regulatory approvals, at which point AMO was rebranded as Johnson & Johnson Vision, integrating it as a new business unit within Johnson & Johnson's Medical Devices segment. In 2023, as part of Johnson & Johnson's corporate restructuring, the Medical Devices segment was reorganized into Johnson & Johnson MedTech, with Vision continuing as a key division. This acquisition marked Johnson & Johnson's strategic entry into the surgical ophthalmology space, combining AMO's established portfolio in cataract surgery, laser refractive procedures, and consumer eye drops with the company's existing strengths in contact lenses. The primary rationale for the acquisition was to bolster 's position in the fast-growing eye health sector, one of the largest segments in global healthcare, by creating a comprehensive end-to-end vision care offering. Prior to the deal, held a dominant share in the consumer vision care market through its ACUVUE brand, while AMO brought expertise in surgical innovations addressing conditions like cataracts, a leading cause of preventable blindness affecting millions worldwide. The move aimed to leverage synergies between consumer health distribution and advanced surgical technologies, positioning the combined entity to serve patients across the full spectrum of eye care needs in a market projected to expand significantly due to aging populations and rising demand for vision correction. Following the merger, Johnson & Johnson Vision underwent operational rebranding of facilities and streamlined integration of efforts, including the alignment of Vistakon manufacturing and labs—focused on contact lenses—with AMO's surgical R&D capabilities to accelerate innovation in ophthalmic products. This consolidation emphasized shared resources in and technology development, fostering a unified approach to eye solutions. As part of the broader cultural integration, the new division adopted Johnson & Johnson's longstanding values, which prioritize patient needs, ethical practices, and responsible innovation, embedding these principles into daily operations and decision-making to guide ethical advancements in vision care. In the immediate aftermath, the acquisition delivered measurable early impacts, with the surgical vision business contributing approximately 3.1% to Johnson & Johnson's worldwide operational sales growth in the first quarter of 2018 alone. For the full year, the Medical Devices segment, now enhanced by Vision, reported $27 billion in sales, reflecting a 6.3% operational increase over 2017, driven in part by the added revenue from combined product lines. Regulatory milestones followed swiftly, including approvals for integrated ophthalmic technologies in key markets; for instance, advancements in intraocular lenses received clearance in Europe and Asia-Pacific regions starting in 2018, enabling broader global rollout of unified surgical and consumer offerings.

Product Portfolio

Contact Lenses

Vision's contact lens portfolio centers on the ACUVUE® brand family, which includes key offerings like 1-Day ACUVUE® MOIST and ACUVUE® OASYS®. The 1-Day ACUVUE® MOIST, launched in 2007, utilizes etafilcon A, a material designed for daily disposables that incorporates LACREON® Technology to release a cushion of moisture throughout the day, promoting all-day comfort for users with dry eyes. ACUVUE® OASYS®, introduced in 2005, features senofilcon A, a material with high oxygen permeability (Dk/t of 147 for bi-weekly versions), enabling extended wear while reducing dryness through Hydraclear® PLUS technology that stabilizes the tear film. Material innovations in the ACUVUE® lineup emphasize and hydration, with senofilcon A providing Dk/t values exceeding 140 in many models to support corneal health during prolonged use, and etafilcon A offering 58% for daily disposables focused on retention. The brand extends to specialized designs, including multifocal lenses for and toric options for , which incorporate Blink Stabilized® Design to maintain orientation and stability on the eye. All ACUVUE® lenses include built-in UV protection, blocking approximately 97% of UVB rays and 82% of UVA rays across the portfolio. Prescription ranges typically cover from -12.00 to +8.00 diopters and hyperopia, accommodating a broad spectrum of vision needs. In the market, Johnson & Johnson Vision holds a leading position in colored and cosmetic lenses through products like 1-Day ACUVUE® DEFINE®, which enhance natural with subtle iris-inspired patterns and were expanded with new collections around 2020. The company produces over 1.7 billion contact lenses annually, underscoring its scale in daily and specialty wear segments. Clinical studies demonstrate strong comfort performance, with users reporting sustained satisfaction in 16-hour wear trials, where lenses like ACUVUE® OASYS® maintained hydration and reduced end-of-day dryness compared to competitors. A notable 2025 update is the launch of ACUVUE® OASYS MAX 1-Day Multifocal for , the first daily disposable toric multifocal lens combining TearStable™ Technology for enhanced tear film stability and all-day hydration with OptiBlue™ Light Filter to address blue-violet light exposure. This innovation targets presbyopic astigmats, providing clear vision at all distances while prioritizing comfort in extended wear scenarios.

Surgical Vision Products

Johnson & Johnson Vision's surgical portfolio focuses on advanced intraocular lenses (IOLs) and procedural systems for and refractive surgeries, enabling precise corrections for , , and refractive errors. The TECNIS family of IOLs represents a of this lineup, designed to restore a broad range of vision post- surgery. For instance, the TECNIS IOL, FDA-approved in 2021, is a hybrid presbyopia-correcting lens that combines diffractive and refractive to provide continuous vision from distance to near, featuring a +3.25 D add power for enhanced near vision capabilities. This IOL addresses common limitations of traditional multifocals by minimizing visual disruptions while extending . Building on this, the TECNIS IOL, launched in the United States in late 2024 and expanded internationally in 2025, offers full visual range correction with exceptional performance in low-light conditions, delivering crisp distance, intermediate, and near vision through its advanced optic design. Complementing the IOL offerings, surgical devices like the VERITAS Vision System support efficient during procedures. Introduced in 2021 with FDA clearance, this modular platform enhances surgeon control through hybrid fluidics and dual-pump technology (peristaltic and Venturi modes), promoting procedural stability and patient safety; clinical evaluations in 2022 confirmed its effectiveness in reducing surgical times and improving . For refractive applications, the iDESIGN Advanced System enables personalized treatments by integrating topographic and data to map over 1,200 eye measurements, allowing customized patterns that address both lower- and higher-order aberrations. FDA-approved in 2018, it facilitates topo-integrated, wavefront-guided procedures for optimized visual outcomes. In , the VISX S4 IR , acquired through Advanced Medical Optics (AMO) in 2005, remains a key asset for treating moderate to high . Originally FDA-approved around 2002 for myopic corrections up to -12 D with , it supports wavefront-guided ablations to refine corneal shape precisely. Clinical outcomes for TECNIS IOLs demonstrate strong , with studies showing approximately 90% of patients achieving 20/20 or better uncorrected distance vision, alongside high satisfaction rates for intermediate and near tasks. Wavefront-guided treatments, such as those using the iDESIGN system with the STAR S4 IR laser, significantly reduce postoperative visual disturbances like halos compared to conventional methods, enhancing quality. Looking to recent advancements, the TECNIS PureSee IOL was showcased at the 2025 European Society of Cataract and Refractive Surgeons (ESCRS) meeting, highlighting its purely refractive extended depth-of-focus design for correction. This IOL delivers spectacle-independent vision across distances with improved optical quality, including reduced chromatic aberrations through its continuous-power profile, as evidenced by real-world data from multicenter studies presented at the event.

Consumer and Diagnostic Solutions

Johnson & Johnson Vision's consumer and diagnostic solutions focus on non-invasive tools and over-the-counter products to support dry eye management and vision screening, complementing professional eye care practices. These offerings address common ocular surface issues affecting millions worldwide, with an emphasis on improving comfort and early detection without invasive procedures. In 2023, Johnson & Johnson Vision divested its consumer eye health brands, including Blink OTC eye drops, to . A key component of dry eye treatments is the LipiFlow Thermal Pulsation System, acquired through the 2017 purchase of TearScience, Inc., which applies localized heat and intermittent pressure to eyelids for (MGD), the leading cause of evaporative dry eye. Clinical studies demonstrate that LipiFlow improves gland function and reduces symptoms in patients with MGD, providing a 12-minute in-office procedure that enhances tear film stability. The system integrates with consumer-facing education to encourage ongoing ocular surface health maintenance. Diagnostic products include the LipiView II Ocular Surface Interferometer, also from the TearScience integration in 2017, which non-invasively images the tear film layer and with nanometer precision to quantify dry eye severity. This tool supports vision screening by identifying MGD in 60% of wearers and 63% of pre-surgical patients, enabling targeted interventions before procedures like . J&J Vision complements this with the Evaluator, a handheld instrument for assessing expression during exams, aligning with ASCRS guidelines for MGD evaluation. For contact lens care, ACUVUE RevitaLens Multi-Purpose Disinfecting Solution offers all-day hydration and disinfection, with a formula that maintains lens moisture for extended wear comfort. is enhanced through at-home self-care options, such as single-use formulations for on-the-go dry eye relief, and partnerships with major retailers like and Amazon for widespread OTC distribution of remaining products. These collaborations ensure broad availability, supporting on allergy-related irritation via integrated dropper designs for precise application.

Recalls and Safety Issues

Major Product Recalls

In 2010, Johnson & Johnson Vision issued a voluntary recall of approximately 100,000 boxes of 1-Day Acuvue and Acuvue TruEye contact lenses due to consumer complaints of eye irritation stemming from equipment failure during the rinsing process at a facility . The issue affected products distributed primarily in and , prompting notifications to distributors and users; no vision damage was reported. The following year, in 2007, Advanced Medical Optics (AMO) recalled its Complete MoisturePlus multipurpose solution after a Centers for Disease Control and Prevention (CDC) investigation linked it to 138 confirmed cases of , a rare but severe corneal infection among soft wearers. The recall was initiated voluntarily as a precaution, with the CDC identifying the solution's inadequate disinfection efficacy against the parasite as the primary risk factor, particularly when combined with poor hygiene practices like showering with lenses. The product was ultimately discontinued, and users were urged to switch to alternative solutions, affecting millions of bottles distributed nationwide and leading to heightened public awareness campaigns on lens care safety. In 2018, Johnson & Johnson Vision conducted a Class II FDA recall (designated Z-2916-2018) for 1-Day ACUVUE MOIST contact lenses due to packaging defects that could compromise sterility, impacting around 806,000 units produced in specific lots. The issue involved potential nonconformities in the blister packaging process, raising concerns about foreign matter or incomplete seals that might lead to eye discomfort or upon insertion. The recall was limited to affected master lots distributed in the U.S., with consumers instructed to discard and replace the lenses; it was officially terminated by the FDA in December 2021 after remediation efforts confirmed resolved manufacturing controls. In June 2025, Johnson & Johnson Vision voluntarily recalled select lots of Acuvue Oasys Max 1-Day Multifocal contact lenses due to a high density of microbubbles that could cause visual disturbances upon insertion. The issue was identified during quality testing and affected products distributed in multiple countries, including ; consumers were advised to return the lenses, with no adverse events reported as of November 2025. Across these incidents, no fatalities were reported, but they resulted in thousands of consumer notifications and product returns, underscoring the importance of vigilant in vision care. The cumulative financial impact on exceeded $100 million, encompassing recall logistics, lost sales, and remediation costs. These events prompted brief regulatory scrutiny, though detailed outcomes are addressed in broader oversight discussions.

Regulatory Responses and Outcomes

Following the 2007 voluntary recall of Complete MoisturePlus multipurpose contact lens solution by Advanced Medical Optics (AMO), acquired by Abbott Laboratories in 2009 and subsequently by Johnson & Johnson Vision in 2017, the U.S. Food and Drug Administration (FDA) issued Form 483 observations to AMO citing failures in quality system regulations, including inadequate reporting of adverse events related to Acanthamoeba keratitis infections and insufficient investigation of manufacturing processes. These actions prompted AMO to enhance its quality controls, though no formal consent decree was imposed specifically on the vision care division at that time. In 2018, Johnson & Johnson Vision initiated a Class II recall of 1-Day Acuvue Moist contact lenses due to packaging nonconformities, leading to FDA oversight but no subsequent warning letters for sterility issues in the division's records. Legal proceedings stemming from the MoisturePlus incident resulted in a settlement in 2011, providing eligible consumers with full cash refunds or coupons for returned products, addressing claims of inadequate warnings about risks. No criminal charges were filed against Johnson & Johnson Vision or its predecessors, but the company has faced ongoing civil litigation related to product safety, with monitoring by regulatory bodies continuing through 2025 to ensure compliance with current good manufacturing practices. In response to these events, Johnson & Johnson Vision implemented enhanced systems aligned with standards for medical devices, focusing on risk-based upgrades across its facilities post-2017 to prevent and defects. The company has also integrated advanced technologies into , contributing to broader operational improvements in defect detection and . By 2025, post-recall audits for ophthalmic products, including intraocular lenses like the TECNIS Eyhance recalled in 2023 for potential unintended toric fiducial marks on the lenses, led to refined sterility assurance protocols under FDA guidance, emphasizing microbial controls in production. Johnson & Johnson Vision expanded collaborations with the International Agency for the Prevention of Blindness (IAPB) to promote global eye care safety standards, supporting initiatives for infection prevention and access to safe vision products. These regulatory engagements have fostered greater transparency, with issuing annual Health for Humanity reports that detail safety metrics and compliance efforts, influencing industry-wide adoption of stringent standards for solutions and ophthalmic devices.

References

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