Lens, Intraocular, Toric Optics
Ophthalmic · 21 CFR 886.3600
Recent MDR events
7,999 adverse event reports on file
- Clareon TruPlus Toric Aspheric UV Absorbing IOL w/ AutonoMe Delivery SystemJul 31, 2026MalfunctionAlcon Laboratories Ireland Ltd.9612169-2026-01740
- Clareon Vivity Toric Extended Vision Hydrophobic IOLJul 31, 2026MalfunctionAlcon Research, Llc - Huntington1119421-2026-01591
- Clareon Vivity Toric Extended Vision UV Absorbing IOL w/AutonoME Delivery SystemJul 31, 2026MalfunctionAlcon Laboratories Ireland Ltd.9612169-2026-01748
- Clareon Vivity Toric Extended Vision UV Absorbing IOLJul 31, 2026InjuryAlcon Research, Llc - Huntington1119421-2026-01595
- Clareon Toric IOLJul 31, 2026InjuryAlcon Laboratories Ireland Ltd.9612169-2026-01750
- CLAREON PANOPTIX PRO Toric Trifocal UV Absorbing IOLJul 31, 2026InjuryAlcon Research, Llc - Huntington1119421-2026-01600
- CLAREON PANOPTIX PRO Trifocal TORIC IOL w/AutonoME Delivery SystemJul 31, 2026InjuryAlcon Laboratories Ireland Ltd.9612169-2026-01751
- TECNIS IOLJul 31, 2026MalfunctionAmo Puerto Rico Mfg. Inc.3012236936-2026-000207
- Clareon Vivity Toric Extended Vision Hydrophobic IOLJul 31, 2026InjuryAlcon Laboratories Ireland Ltd.9612169-2026-01752
- Clareon Toric IOLJul 30, 2026InjuryAlcon Research, Llc - Huntington1119421-2026-01582
Event type breakdown
Recalls
4 recall events for this product code
- Johnson & Johnson Surgical Vision, Inc.Open, ClassifiedJan 16, 2024
TECNIS Toric II OptiBlue IOL Models ZCW
Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks.
Z-0735-2024 · View FDA record ↗ - Johnson & Johnson Surgical Vision IncTerminatedUnknown
TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a si
Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit. Product was released in error based on the results of additional testing performed during the investigation into release testing nonconformance.
Z-0028-2022 · View FDA record ↗ - Bausch & Lomb Surgical, Inc.TerminatedUnknown
MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag
Product may be missing toric axis marks.
Z-0519-2021 · View FDA record ↗ - Johnson & Johnson Surgical Vision IncTerminatedUnknown
TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
Due to the release of nonconforming Intraocular Lenses (IOLs).
Z-1163-2021 · View FDA record ↗
Registered firms
35 firms currently registered for this product code
Pt. Ciba Vision Batam
BATAM ISLAND Riau, ID
Alcon Research, Llc
HUNTINGTON, WV, US
Staar Surgical Company
Tustin, CA, US
Alcon Laboratories Ireland Ltd.
CORK, IE
Amo Puerto Rico Manufacturing, Inc
ANASCO, PR, US
Staar Surgical Company
MONROVIA, CA, US
Alcon Research, Llc
Lesage, WV, US
Bausch & Lomb Incorporated
Rochester, NY, US
Rayner Intraocular Lenses Limited
Worthing West Sussex, GB
Synergy Health Sterilisation Uk Ltd
Thorne Doncaster, GB
Steris Corporation De Republica Dominicana, S.r.l.
Santo Domingo, DO
Bausch & Lomb Incorporated
CLEARWATER, FL, US
Amo Groningen Bv
GRONINGEN, NL
Millennium Biomedical, Inc.
POMONA, CA, US
Bausch & Lomb Incorporated
WILMINGTON, MA, US
Alcon Laboratories Belgium
Puurs-Sint-Amands Antwerpen, BE
Alcon Research, Llc
Fort Worth, TX, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.