Adverse Events — Clinical Updates
Bausch + Lomb Issues Voluntary Recall of Several Lenses
On March 27, Bausch + Lomb issued a voluntary recall of all enVista Envy and enVista Aspire IOLs, as well as certain enVista monofocal lenses due to reports of toxic anterior segment syndrome (TASS) in conjunction with enVista® intraocular lenses (IOLs). The voluntary recall was delineated by model #/sku rather than lot #. Recalled lenses are listed in the chart below.
The cause of the cases is unclear and the recall will remain in place while the company investigates the matter. The company noted that ‘all reported Toxic Anterior Segment Syndrome (TASS) cases associated with enVista lenses responded quickly to treatment and did not result in removal of the lens. Only a handful involved intervention beyond standard of care.’ Click here for a TASS fact sheet.
As always, ASRS encourages members to report any adverse events to the FDA Medwatch Voluntary Reporting Form and to the ASRS Adverse Events Reporting System.
