Bausch + Lomb To Return EnVista Intraocular Lenses To Market Following Recall; Stock Up

(RTTNews) - Eye health firm Bausch + Lomb Corp. (BLCO) announced Thursday that it is returning the recently recalled enVista Intraocular Lenses to market after identifying the cause for the issue and confirming the affected lots.

In pre-market activity on the NYSE, Bausch + Lomb shares were gaining around 5.6 percent to trade at $13.45.

It was in early April that the company initiated the recall of certain intraocular lenses or IOLs on its enVista platform, following increased number of reports of toxic anterior segment syndrome or TASS, a potential complication in any cataract surgery.

The company then had noted that the cause of the issue could not immediately be explained. The recall involved enVista Aspire, enVista Envy and certain enVista Monofocal Intraocular Lenses in the U.S.

In a statement, the company now noted that it has identified the event that led to its recent recall of IOLs on the enVista platform.

Following the probe, in collaboration with a globally recognized 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, it said.

With this, Bausch + Lomb said it 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 now 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.

Further, timing for market reentry in other countries will be determined on a case-by-case basis in collaboration with health authorities.

Brent Saunders, chairman and CEO, Bausch + Lomb, said, "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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