Bausch + Lomb Returning enVista® Intraocular Lenses to Market Following Voluntary Recall
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VAUGHAN, Ontario — Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced it has identified the event that led to its recent voluntary recall of intraocular lenses (IOLs) on the enVista platform. Now that the cause and affected lots have been confirmed, the company will return these models to market.
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'We voluntarily recalled these lenses because patient safety dictates every decision we make,' said Brent Saunders, chairman and CEO, 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.'
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Investigation Results
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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 tight correlation between the lots in question and reported TASS cases is clear, as highlighted in the recall timeline.
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Bausch + Lomb continues to share its findings with the U.S. Food & Drug Administration and other regulatory authorities.
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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.
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With these new processes in place, Bausch + Lomb has returned to full production of all enVista IOLs. In the following weeks the company will return to full market supply in the U.S.; timing for market reentry in other countries will be determined on a case-by-case basis in collaboration with health authorities.
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See a message from Saunders to customers and TASS fact sheet for additional information. Bausch + Lomb will discuss financial impacts of the voluntary recall on its April 30 first-quarter earnings call.
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About Bausch + Lomb
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Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from birth through every phase of life. Its comprehensive portfolio of approximately 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,500 employees and a presence in approximately 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario, with corporate offices in Bridgewater, New Jersey. For more information, visit www.bausch.com and connect with us on Facebook, Instagram, LinkedIn, X and YouTube.
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Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words 'anticipates,' 'hopes,' 'expects,' 'intends,' 'plans,' 'should,' 'could,' 'would,' 'will,' 'may,' 'believes,' 'estimates,' 'potential,' 'target,' or 'continue' and variations or similar expressions. Forward-looking statements include statements regarding the recent voluntary recall of certain of our enVista IOLs, including the anticipated timing of market reentry and return to full market supply in the U.S. and other countries. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb's filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators (including the company's Annual Report on Form 10-K for the year ended Dec. 31, 2024 and its most recent quarterly filings). They also include risks relating to the voluntary recall of certain of our enVista® IOL products, including the timing of market reentry and return to full market supply, the success of the enhanced inspection protocols and more explicit standards for third party suppliers we have implemented for IOLs and any additional actions that may be taken by the company and/or regulatory authorities with respect to the recall or as part of the return to market of these products. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
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Contacts
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Media Contact:
Caryn Marshall
caryn.marshall@bausch.com
(908) 493-1381
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