Just weeks after initiating a voluntary recall of select intraocular lenses (IOLs), Bausch + Lomb Corporation announced those lenses will now return to market.
First, some background on this situation.
In late March, the company took a number of its IOL models off the market following an increase in reports of toxic anterior segment syndrome (TASS)—read up on that here—connected to implantations of specific enVista lenses across the United States.
Included among these recalled products:
- EE (monofocal)
- ETE (monofocal toric)
- enVista Aspire (toric and monofocal)
- enVista Envy (toric and monofocal)
Notably: All thoseTASS cases were reported to respond quickly to treatment and did not require the removal of the IOLs.
And was the source of this problem ever identified?
In its original recall announcement, B+L Chairman and CEO Brent Saunders had stated that the root cause was “unclear,” and that the recalls were made out of an abundance of caution.
And since then, an ongoing investigation of testing and analysis has ensued.
To note: This investigation was conducted in collaboration with:
- A global TASS expert
- An advisory group of nearly 30 cataract surgeons, including from the American Society of Cataract and Refractive Surgeons (ASCRS)
So what’s the latest?
Based on this investigation, the company announced on Thursday that it had determined “the issue stemmed from raw material used in certain lots [of its IOLs] that was delivered by a different vendor.”
Notably: B+L’s confidence in this determination came from a “clear” tight correlation between the lots in question and the reported TASS cases.
- Check out this timeline of the product recall.
“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,” Saunders stated.
And what is the company doing to ensure future IOL safety?
B+L shared that it has implemented "enhanced inspection protocols” for its IOLs—including “more explicit standards” for how the monomers comprising these products are prepared by the vendors it utilizes.
Other few potential examples of what these protocols may entail includes:
- More rigorous checks and procedures to ensure the lenses’ quality and safety prior to use
- More detailed quality control checks
Good to know. Now about this return-to-market plan …
Full production of all enVista IOLs has resumed, according to B+L—complete with its new protocols in place.
The plan: For the company to turn to full market supply in the United States within the next few weeks.
As for outside the U.S.: “Timing for market reentry in other countries will be determined on a case-by-case basis in collaboration with health authorities,” the company stated.