Dive Brief:

• Bausch + Lomb has recalled intraocular lenses in response to a growing number of reports that some patients are experiencing inflammatory reactions in their eyes, the company said Thursday.
• The company has seen a rise in reports of toxic anterior segment syndrome in recipients of its Envista Envy IOLs in the past few weeks, according to a letter to customers. In recent days, Bausch + Lomb received reports of TASS linked to Envista Aspire and Envista monofocal lenses.
• Bausch + Lomb is recalling all Envy and Aspire IOLs and certain lots of Envista monofocal lenses. J.P. Morgan analysts estimated 1% of total company sales could be at risk, but their counterparts at Evercore ISI outlined a scenario in which the issue could be resolved in the next six months.

Dive Insight:

IOLs are a growth driver for Bausch + Lomb. With launches of Envista Envy and Aspire underway in the U.S. and expanding to other markets, the company reported a 67% increase in sales of premium IOLs in the fourth quarter. CFO Sam Eldessouky said on a February earnings call that Envista Envy and Aspire were “showing strong early results.”

Now, the company is recalling all Envista Envy and Aspire lenses in response to reports of TASS, an inflammatory reaction that happens when toxic substances enter the eye during surgery. The complication typically develops 12 to 48 hours after surgery. 

Bausch + Lomb said all the cases in users of its IOLs responded quickly to treatment and did not result in lens removal. CEO Brent Saunders said in the letter to customers that “only a handful” of the cases involved intervention beyond standard of care. Bausch + Lomb is unsure why some patients are having the reaction and is testing lenses, analyzing reports and talking to specialists to learn more.

The company has yet to share full details of the recall. Saunders said there are “steps we need to take to nail down logistics,” adding that the company will give customers detailed instructions about what to do with stock and what to tell patients in the coming days. 

Analysts tried to predict the impact of the recall on Bausch + Lomb’s future financial results. J.P. Morgan analysts estimated the Envista product line accounts for 30% to 40% of the company’s implantable business, suggesting about $70 million to $90 million in 2025 revenues “could be at risk.” The revenues amount to more than 1% of Bausch + Lomb’s total sales. 

The analysts said it is too early to discuss any financial impact. However, because the recall was not factored into the company’s full-year guidance, “anything beyond a fast resolution will likely result in downside to forecasts, or at a minimum limit upside.”

Evercore ISI analysts said the recall could represent a 1% to 1.5% headwind to growth in 2025. The figure assumes the recall will significantly disrupt the $62 million premium IOL business and have some impact on the $141 million standard lens franchise.

The analysts also described a scenario in which the impact could be reduced by a fast resolution of the recall.

The recall of some lots of Envista monofocal lenses could point to a post-manufacturing packaging issue, the Evercore ISI analysts said. “If so, root cause analysis should be quick … and a process change (not requiring product design changes) could be resolved without an FDA inspection” in the next six months, they wrote.