Lens, Multifocal Intraocular
Ophthalmic · 21 CFR 886.3600
Recent MDR events
14,298 adverse event reports on file
- Clareon PanOptix Trifocal UV Absorbing Intraocular LensJul 31, 2026InjuryAlcon Research, Llc - Huntington1119421-2026-01601
- AcrySof IQ PanOptix Trifocal IOLJul 31, 2026InjuryAlcon Research, Llc - Huntington1119421-2026-01603
- TECNIS Odyssey Toric II IOLJul 31, 2026InjuryAmo Manufacturing Netherlands3012236936-2026-000225
- TECNIS Odyssey Toric II IOLJul 31, 2026MalfunctionAmo Manufacturing Netherlands3012236936-2026-000228
- TECNIS Odyssey Toric II IOLJul 31, 2026InjuryAmo Manufacturing Netherlands3012236936-2026-000227
- TECNIS IOLJul 31, 2026InjuryAmo Puerto Rico Mfg. Inc.3012236936-2026-000223
- TECNIS Odyssey Toric II IOLJul 31, 2026InjuryAmo Manufacturing Netherlands3012236936-2026-000227
- TECNIS Odyssey Toric II IOLJul 31, 2026InjuryAmo Manufacturing Netherlands3012236936-2026-000227
- TECNIS IOLJul 31, 2026InjuryAmo Puerto Rico Mfg. Inc.3012236936-2026-000217
- TECNIS SIMPLICITYJul 31, 2026InjuryAmo Manufacturing Netherlands3012236936-2026-000217
Event type breakdown
Most-reported manufacturers
Recalls
4 recall events for this product code
- Bausch & Lomb Surgical, Inc.Open, ClassifiedMay 2, 2025
Intraocular Lens. enVista Envy IOL, All models starting with EN;
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.
Z-1680-2025 · View FDA record ↗ - Alcon Laboratories, IncTerminatedFeb 15, 2007
AcrySof ReSTOR Intraocular Lens
Intraocular lenses exposed to extreme temperatures while in storage.
Z-0429-2007 · View FDA record ↗ - Alcon Laboratories, IncTerminatedFeb 15, 2007
AcrySof ReSTOR Intraocular Lens
Intraocular lenses exposed to extreme temperatures while in storage.
Z-0430-2007 · View FDA record ↗ - Alcon Laboratories, IncTerminatedFeb 15, 2007
AcrySof Intraocular Lens
Intraocular lenses exposed to extreme temperatures while in storage.
Z-0431-2007 · View FDA record ↗
Registered firms
38 firms currently registered for this product code
Amo Groningen Bv
GRONINGEN, NL
Pt. Ciba Vision Batam
BATAM ISLAND Riau, ID
Alcon Research, Llc
HUNTINGTON, WV, US
Alcon Laboratories Ireland Ltd.
CORK, IE
Amo Puerto Rico Manufacturing, Inc
ANASCO, PR, US
Alcon Research, Llc
Lesage, WV, US
Bausch & Lomb Incorporated
Rochester, NY, US
Synergy Health Sterilisation Uk Ltd
Thorne Doncaster, GB
Steris Corporation De Republica Dominicana, S.r.l.
Santo Domingo, DO
Physiol.s.a
Liege, BE
Lenstec Barbados, Inc.
CHRIST CHURCH, BB
Johnson & Johnson Surgical Vision, Inc.
Irvine, CA, US
Alcon Laboratories Belgium
Puurs-Sint-Amands Antwerpen, BE
Alcon Research, Llc
Fort Worth, TX, US
Lenstec, Inc.
Saint Petersburg, FL, US
Bausch & Lomb Incorporated
CLEARWATER, FL, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.