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The company says it has identified the problem with the help of top American cataract surgeons and the ASCRS.
Bausch + Lomb (Vaughan, Canada) has announced plans to return its enVista® intraocular lens (IOL) platform to market following the completion of its investigation into the cause of a recent voluntary recall.
The company has identified that the toxic anterior segment syndrome (TASS) cases which prompted the recall were linked to specific lots containing raw materials from an alternative vendor. With enhanced quality control measures now in place, Bausch + Lomb has resumed full production of all enVista IOLs.
“We voluntarily recalled these lenses because patient safety dictates every decision we make,” said Brent Saunders, chairman and CEO of Bausch + Lomb. “We wouldn’t bring them back without full confidence in the enVista safety profile, which has been established over years and hundreds of thousands of implants.”
Investigation process
The investigation was conducted in collaboration with a globally recognized TASS expert and an advisory panel comprising nearly 30 leading cataract surgeons, including leadership from the American Society of Cataract and Refractive Surgery (ASCRS).
READ MORE: Stay Tuned for Our Upcoming ASCRS 2025 Coverage Here.
“After a thorough investigation in collaboration with a globally recognized toxic anterior segment syndrome (TASS) expert and an advisory group of nearly 30 top cataract surgeons including American Society of Cataract and Refractive Surgery leadership, the company determined that the issue stemmed from raw material used in certain lots that was delivered by a different vendor,” the company stated in its announcement. “The tight correlation between the lots in question and reported TASS cases is clear, as highlighted in the recall timeline.”
Bausch + Lomb’s enVista recall process. Graphic courtesy of Bausch + Lomb.
The investigation focused on identifying the precise cause of the reported TASS cases, which are inflammatory reactions that can occur following anterior segment surgery. By isolating the issue to specific lots containing raw materials from a different vendor, Bausch + Lomb was able to determine that the fundamental design and manufacturing processes for the enVista platform remain sound.
Future quality control measures
In response to these findings, the company has implemented more stringent inspection protocols for IOLs and established more explicit standards for how the monomers that compose the lenses are prepared by vendors. These enhanced procedures are designed to prevent similar issues from occurring in the future.
“In response to the investigation, Bausch + Lomb has implemented enhanced inspection protocols for IOLs, as well as more explicit standards for how the monomers that make up its lenses are prepared by vendors,” the company’s statement announced.
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The company’s proactive approach included not only identifying the source of the problem but also developing comprehensive solutions to strengthen its quality assurance processes across the entire manufacturing chain. This includes additional inspection points throughout the manufacturing process.
Market return timeline
With these new processes in place, Bausch + Lomb confirmed it “has returned to full production of all enVista IOLs.” U.S. practitioners can expect full market supply to resume in the coming weeks, allowing surgeons to reincorporate these lenses into their surgical options for cataract patients.
Bausch + Lomb continues to share its findings with the FDA and other regulatory bodies to ensure transparency throughout the process. The company believes this collaborative approach with regulatory authorities has facilitated the relatively swift return of the product to market while maintaining the highest standards of patient safety.
For the ophthalmic community, the return of enVista IOLs represents a welcome development, restoring an important option for surgeons and their patients. The company’s handling of the recall—from the initial voluntary action to the thorough investigation and enhanced quality measures—reflects the importance of prioritizing patient safety in medical device manufacturing.
Editor’s Note: For more, please refer to Bausch + Lomb’s press release on enVista’s return to the market.
