Lens, Multifocal Intraocular
FDA adverse event reports and recall history for lens, multifocal intraocular (product code MFK), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 14,177
- Deaths
- 0
- Injuries
- 10,821
- Malfunctions
- 2,347
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-05-02Open, ClassifiedProcess control
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
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.
- 2007-02-15TerminatedOther
AcrySof ReSTOR Intraocular Lens
Intraocular lenses exposed to extreme temperatures while in storage.
- 2007-02-15TerminatedOther
AcrySof ReSTOR Intraocular Lens
Intraocular lenses exposed to extreme temperatures while in storage.
- 2007-02-15TerminatedOther
AcrySof Intraocular Lens
Intraocular lenses exposed to extreme temperatures while in storage.
Monitor lens, multifocal intraocular automatically
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