- Bausch + Lomb (BLCO, Financial) is resuming the market supply of its enVista® Intraocular Lenses after addressing a recent voluntary recall.
- The recall was due to raw material issues in certain lots, which have now been resolved.
- The company has implemented enhanced inspection protocols and confirmed the safety of the lenses.
Bausch + Lomb Corporation (BLCO), a leading global eye health company, announced the reintroduction of its enVista® Intraocular Lenses (IOLs) to the market following a voluntary recall. The recall was initiated after the discovery of a problem with raw materials supplied by a different vendor, which affected specific lots of the lenses.
After a comprehensive investigation alongside a toxic anterior segment syndrome (TASS) expert and a panel of nearly 30 top cataract surgeons, Bausch + Lomb has confirmed the issue and traced it back to these specific lots. With the problem identified and rectified, the company is confident in the safety profile of the enVista IOLs.
In response to the incident, Bausch + Lomb has established enhanced inspection protocols and more stringent standards for the preparation of monomers used in the lenses. These measures are expected to improve quality control and ensure patient safety, the company’s top priority.
The company has resumed full production of the enVista IOLs and plans to replenish the U.S. market supply in the coming weeks. The timeline for reentry into other international markets will be coordinated with respective health authorities.
Additional insights on the financial implications of the recall are expected to be shared during Bausch + Lomb's first-quarter earnings call on April 30.
