An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could result in the need for optical or surgical correction.
In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
Product may be missing toric axis marks.
The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
Cosmetic imperfections on the surface of some lenses.
Complaints concerning kinked haptics that were occurring during lens delivery.
Haptics breaking during lens loading and insertion.
Haptics breaking during lens loading and insertion.
Lens was manufactured with incorrect raw material.