Lenses, Soft Contact, Extended Wear
Ophthalmic · 21 CFR 886.5925
Recent MDR events
3,063 adverse event reports on file
- ACUVUE® OASYS®Jul 30, 2026InjuryJohnson & Johnson Vision Care, Inc. - Us1057985-2026-0000060
- ACUVUE® OASYS®Jul 30, 2026InjuryJohnson & Johnson Vision Care, Inc. - Us1057985-2026-0000059
- Biofinity Toric (comfilcon A)Jul 29, 2026InjuryCoopervision Manufacturing Puerto Rico, Llc2640128-2026-00016
- Biofinity Toric (comfilcon A)Jul 29, 2026InjuryCoopervision Manufacturing Puerto Rico, Llc2640128-2026-00017
- ACUVUE® OASYS® for ASTIGMATISMJul 29, 2026InjuryJohnson & Johnson Vision Care, Inc. - Us1057985-2026-0000056
- Biofinity Sphere (comfilcon A)Jul 27, 2026InjuryCoopervision Manufacturing, Ltd.9614392-2026-00026
- PRECISION7Jul 15, 2026InjuryCiba Vision Gmbh9610813-2026-00032
- BIOFINITY TORIC (COMFILCON A)Jul 7, 2026InjuryCoopervision Manufacturing, Ltd.9614392-2026-00024
- BIOFINITY TORIC (COMFILCON A)Jul 7, 2026InjuryCoopervision Manufacturing, Ltd.9614392-2026-00025
- ACUVUE® OASYS® FOR ASTIGMATISMJul 6, 2026InjuryJohnson & Johnson Vision Care, Inc. - Us1057985-2026-0000048
Event type breakdown
Recalls
26 recall events for this product code
- CooperVision, Inc.Open, ClassifiedJul 23, 2025
Biofinity XR Toric Contact Lens
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
Z-2165-2025 · View FDA record ↗ - CooperVision, Inc.Open, ClassifiedJul 23, 2025
Biofinity Toric Multifocal Contact Lens
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
Z-2166-2025 · View FDA record ↗ - CooperVision, Inc.Open, ClassifiedSep 30, 2024
BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and
Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
Z-3310-2024 · View FDA record ↗ - CooperVision, Inc.Open, ClassifiedSep 30, 2024
Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in apha
Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
Z-3311-2024 · View FDA record ↗ - CooperVision, Inc.Open, ClassifiedMar 1, 2023
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
Z-1197-2023 · View FDA record ↗ - CooperVision, Inc.Open, ClassifiedMar 1, 2023
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
Z-1198-2023 · View FDA record ↗ - CooperVision Inc.TerminatedJan 27, 2020
Coopervision Vertex Toric /2 Clear Toric-
Incorrect power of lenses than the expected
Z-1227-2020 · View FDA record ↗ - CooperVision Inc.TerminatedJan 27, 2020
Coopervision Vertex Toric /2 Clear Toric-
Incorrect power of lenses than the expected
Z-1228-2020 · View FDA record ↗ - Intertrade Imports Inc.TerminatedJan 12, 2015
Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm.
A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses. I Color Color Complete brand color contact lenses are unapproved medical devices.
Z-0950-2015 · View FDA record ↗ - Intertrade Imports Inc.TerminatedJan 12, 2015
Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm,
A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses, product is not sterile. I Color Color Complete brand color contact lenses are unapproved medical devices.
Z-0951-2015 · View FDA record ↗
Registered firms
121 firms currently registered for this product code
Kelabit S.r.o.
Ostrava Moravskoslezsky Kraj, CZ
Go Pro Now Ltd
Hexham Northumberland, GB
Bausch & Lomb Incorporated
Rochester, NY, US
Harleigh (malaysia) Sdn. Bhd.
Johor Bahru, MY
1462287 Bc Unlimited Liability Company
Surry British Columbia, CA
Coopervision, Inc.
SCOTTSVILLE, NY, US
Kits Eyecare Ltd
VANCOUVER British Columbia, CA
Imperial Optical, Inc
TOWN OF MOUNT ROYAL, QUEBEC, CA
7051395 Canada Inc Dba Hta Direct Sourcing
Champlain, NY, US
Alcon Canada
Mississauga Ontario, CA
Integrated Supply Chain Sdn. Bhd.
Gelang Patah Johor, MY
Coopervision Manufacturing Ltd
Fareham Hampshire, GB
Fine Vision Optical Company
Mumbai Maharashtra, IN
Infar International Pte Ltd
Singapore Central Singapore, SG
Hood Container Corporation
Rural Hall, NC, US
Bausch & Lomb Incorporated
CLEARWATER, FL, US
Enlaces Corporativos 55 Del Norte S.a. De C.v.
MEXICO Ciudad de Mexico, MX
Coopervision Manufacturing Puerto Rico, Llc
Juana Diaz, PR, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.
PMA approvals
37 premarket approvals for this product code
- Alcon Laboratories, Inc.Apr 25, 2023
P220007 · Precision7; Precision7 for Astigmatism; Precision7 Multifocal; Precision7 Multifocal Toric (serafilcon A) Soft Conta
- Bausch and Lomb, Inc.,Apr 30, 2018
P170035 · Bausch + Lomb Ultra (samfilcon A) Contact Lenses
- CooperVision, Inc.Nov 19, 2008
P080011 · BIOFINITY (COMFILCON A)
- Vistakon, Division of Johnson & Johnson Vision CarDec 20, 2005
P040045 · VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
- Alcon Laboratories, Inc.Oct 12, 2001
P000030 · FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES
- Alcon Laboratories, Inc.Oct 11, 2001
P010019 · FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
- Johnson & Johnson Vision Care, Inc.Feb 16, 2001
P990085 · VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
- Westcon Contact Lens Co., Inc.Aug 22, 2000
P990072 · W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES