Dive Brief:

• Bausch + Lomb will return intraocular lenses to the market after identifying the cause of adverse events that triggered a voluntary recall in March.
• The eye health specialist, which announced the decision on Thursday, pulled products from the market last month in response to an increase in reports of toxic anterior segment syndrome. Bausch + Lomb outlined plans to resume sales after identifying a raw material from a vendor as the cause of the adverse events.
• While the lenses were only off the market for weeks, a high volume cataract doctor previously told Needham analysts he would wait at least six months before readopting Bausch + Lomb’s Envista Envy lenses.

Dive Insight:

Bausch + Lomb initially saw a rise in TASS in recipients of its Envista Envy lenses. Then, the company began receiving reports in patients who received its Envista Aspire and Envista monofocal lenses. Bausch + Lomb responded by voluntarily recalling all Envy and Aspire IOLs and certain lots of Envista monofocal lenses. The company was unsure of the cause of the adverse events when it recalled the devices.

An analysis of the timing of the reports has convinced Bausch + Lomb that raw material delivered by a vendor was the source of the problem. Around 90% of reported TASS cases aligned with the use of the raw material, the company said.

The TASS reporting rate for the 6.5 million Envista lenses implanted before the recall was around 0.01%, according to Bausch + Lomb, compared to an industry all-cause TASS reporting rate of 0.22%. Reports linked to Bausch + Lomb lenses spiked in the fall and winter of 2024, peaking in December, and the Envista TASS reporting rate was 0.25% when the company identified the safety signal.

Bausch + Lomb plans to return to full market supply in the U.S. in the following weeks. The company will determine the timing of its return to other markets on a case-by-case basis in collaboration with health authorities. 

The devices were off the market for less time than analysts speculated when the recall began. Evercore ISI analysts, writing in a note to investors last month, proposed a scenario in which the devices could be back on the market in six months. J.P. Morgan analysts estimated in a note in March that $70 million to $90 million of revenue could be at risk this year.

Analysts are still unsure about the financial impact on Bausch + Lomb and its competitors. J.P. Morgan analysts said in a note to investors Thursday that they “expect modest downside, or at minimum less upside, to results in the Surgical business in 2Q.” Needham analysts said in another note Thursday that they “expect the net impact to be a headwind to 2025 guidance.” 

Needham analysts added that the recall was a short-term opportunity for Rxsight, and the re-launch of Envista lenses “is an incremental negative” for the company. Rxsight CEO Ron Kurtz discussed the recall on an earnings call this month, telling analysts it is “largely not going to be as impactful on us as it would be for some of the other competitors.”

Alcon “likely saw some uptick in Panoptix volumes over the last month,” Needham analysts said. Bausch + Lomb is likely to be “aggressive with the re-launch, so it could, in effect, have a similar impact as a ‘new’ launch,” Needham analysts said.

The timing roughly coincides with Alcon’s launch of Panoptix Pro, and the analysts expect the net impact to be neutral to a slight positive for Alcon.