COOPERVISION, INC.
13 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (13)
Registered facilities (14)
- BLANCHARD VISION CORP. FEI 3002807465 · CA
- CooperVision Manufacturing, LTD. FEI 3008586477 · GB
- Paragon Vision Sciences, Inc. FEI 3013398957 · AZ
- COOPERVISION, INC. FEI 1314956 · NY
- CooperVision Manufacturing Ltd FEI 3006514242 · GB
- COOPERVISION Manufacturing Puerto Rico, LLC FEI 3002911336 · PR
- COOPERVISION MANUFACTURING, LTD. FEI 3002806417 · GB
- CooperVision, Inc. FEI 3011771819 · NY
- COOPERVISION INC. FEI 3005724763 · NY
- CooperVision CL KFT FEI 3009108089 · HU
- CooperVision Manufacturing Costa Rica SRL FEI 3012123291 · CR
- SYNERGEYES, INC. FEI 3005087645 · CA
- CooperVision Limited FEI 3002807783 · GB
- COOPERVISION MANUFACTURING, LTD. FEI 3003981983 · GB
Recalls & enforcement
20261 record
- Class IIOngoing2026-08-12A small number of lenses within the affected lot are of the incorrect power.
20253 records
- Class IIOngoing2025-08-22One lot manufactured with an invalid sterilization cycle.
- Class IIOngoing2025-06-16Lens blisters may have an incomplete or leaking seal which may render them unsterile.
- Class IIOngoing2025-02-27a limited number of lots were manufactured with an incorrect cylinder power.
20241 record
- Class IIOngoing2024-08-29Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
20232 records
- Class IIOngoing2023-02-14The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
- Class IIOngoing2023-01-26Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
20221 record
- Class IIOngoing2022-12-27Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
20211 record
- Class IITerminated2021-05-19Misaligned placement of an axis mark can cause the patient to experience blurred vision
20201 record
- Class IITerminated2020-01-13Incorrect power of lenses than the expected
20181 record
- Class IIITerminated2018-02-21The secondary packaging is labeled with an incorrect expiration date.
20171 record
- Class IIITerminated2017-09-01The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister labels. The primary blister reads Biofinity Multifocal Toric in error, and should read Biofinity XR Toric. The outer carton correctly reads Biofinity XR Toric.
20131 record
- Class IITerminated2013-11-20Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “COOPERVISION, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9929062-coopervision-inc/
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