Lens, Contact (other Material) - Daily
Ophthalmic · 21 CFR 886.5916
Recent MDR events
134 adverse event reports on file
- MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSFeb 19, 2026InjuryMenicon Co., Ltd.1000188353-2026-00001
- BOSTON XO2 GAS PERMEABLE CONTACT LENSESFeb 9, 2026InjuryBausch & Lomb IncorporatedMW5183528
- BOSTONSIGHT PROSEAug 26, 2025InjuryBoston Foundation For Sight3006204913-2025-00001
- SYNERGEYES A EP LENSJul 15, 2025InjurySynergeyes, Inc.3005087645-2025-00001
- SYNERGEYES K LENSJul 8, 2024InjurySynergeyes3005087645-2024-00002
- LATITUDEJan 18, 2024MalfunctionVisionary Optics1000123221-2023-00012
- BOSTONSIGHT PROSEJan 8, 2024InjuryBoston Foundation For Sight3006204913-2024-00001
- EUROPA SCLERAL LENSESNov 6, 2023InjuryVisionary Optics, Llc.MW5147863
- SYNERGEYES KC LENSMay 8, 2023InjurySynergeyes3005087645-2023-00007
- DUETTE PROGRESSIVE CN WITH TANGIBLE HYDRAPEGMay 2, 2023InjurySynergeyes3005087645-2023-00006
Event type breakdown
Recalls
5 recall events for this product code
- Boston Foundation For SightOpen, ClassifiedJul 29, 2025
BostonSight SCLERAL Lens
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Z-2190-2025 · View FDA record ↗ - Boston Foundation For SightOpen, ClassifiedJul 29, 2025
BostonSight PROSE Lens.
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Z-2191-2025 · View FDA record ↗ - Bausch & Lomb IncTerminatedMay 27, 2010
Boston ES Rigid Gas Permeable Contact lens manufactured with Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lens Material. Bausch & Lomb, Inc. Wilmington
The amount of D&C #6 Dye added to the formulation exceeded specified amounts.
Z-1705-2010 · View FDA record ↗ - Alden OpticalTerminatedUnknown
Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows:
Vials labeled for the prescriptions contained incorrect lenses
Z-2981-2018 · View FDA record ↗ - Alden OpticalTerminatedUnknown
Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows:
Vials labeled for the prescriptions contained incorrect lenses
Z-2982-2018 · View FDA record ↗
Registered firms
266 firms currently registered for this product code
Bausch & Lomb Incorporated
Rochester, NY, US
Biolens Lab
Mohammedia Mohammadia, MA
Visionary Optics, Llc
Front Royal, VA, US
Acculens, Inc.
Golden, CO, US
Art Optical Contact Lens, Inc.
Walker, MI, US
Aurora Gp Lab Inc
Goodyear, AZ, US
Precision Technology Services Ltd
Cambridge Ontario, CA
Bausch & Lomb Incorporated
WILMINGTON, MA, US
Tianjin Mastervision Technology Co., Ltd.
Wuqing District Tianjin, CN
Valley Contax, Inc
Eugene, OR, US
Shinyeyes Inc.
Pasadena, CA, US
Synergy Health Ast, Llc
SAN DIEGO, CA, US
Blanchard Vision Corp.
SHERBROOKE Quebec, CA
Paragon Vision Sciences, Inc.
Gilbert, AZ, US
Menicon Co. Ltd. Global Logistics Center
Yachiyo Chiba, JP
510(k) clearances
118 clearances for this product code
- Zhuhai Fitlens Medical Technology Co., Ltd.Mar 27, 2026
K253822 · GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
- Acuity Polymers, Inc.Nov 1, 2024
K242393 · Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses
- Tianjin Mastervision Technology Co., Ltd.Oct 22, 2024
K241398 · SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses
- Boston Foundation For Sight, Inc. D/B/A BostonsightAug 14, 2024
K241571 · BostonSight® Specialty Lenses
- Acuity Polymers, Inc.Apr 3, 2024
K240618 · Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens
- Visionary Optics, LLCFeb 21, 2024
K233325 · Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)
- Acculens, Inc.Jun 16, 2023
K230910 · NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens
- Acuity Polymers, Inc.Jun 16, 2023
K230965 · Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lens
PMA approvals
2 premarket approvals for this product code