Facility

COOPERVISION Manufacturing Puerto Rico, LLC

13 recall(s) on record — most severe on record: Class II.

Key facts

13recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002911336
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	500 ROAD 584, LOT 7 Juana Diaz, PR, US 00795
Registration status	Active · expires 2026
Parent company	COOPERVISION, INC. (owner-operator 9929062)

Activity by year

Recalls (13)

Devices registered here (2)

Lens, Contact, (Disposable)
Product code MVN (opens in a new tab) · Class II · Ophthalmic · 21 CFR 886.5925
Lenses, Soft Contact, Daily Wear
Product code LPL (opens in a new tab) · Class II · Ophthalmic · 21 CFR 886.5925

Recalls & enforcement

20261 record

Class IIOngoing2026-08-12
A small number of lenses within the affected lot are of the incorrect power.

20253 records

Class IIOngoing2025-08-22
One lot manufactured with an invalid sterilization cycle.
Class IIOngoing2025-06-16
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
Class IIOngoing2025-02-27
a limited number of lots were manufactured with an incorrect cylinder power.

20241 record

Class IIOngoing2024-08-29
Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity

20232 records

Class IIOngoing2023-02-14
The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
Class IIOngoing2023-01-26
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity

20221 record

Class IIOngoing2022-12-27
Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.

20211 record

Class IITerminated2021-05-19
Misaligned placement of an axis mark can cause the patient to experience blurred vision

20201 record

Class IITerminated2020-01-13
Incorrect power of lenses than the expected

20181 record

Class IIITerminated2018-02-21
The secondary packaging is labeled with an incorrect expiration date.

20171 record

Class IIITerminated2017-09-01
The 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 IITerminated2013-11-20
Lots 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. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “COOPERVISION Manufacturing Puerto Rico, LLC (FEI 3002911336) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002911336-coopervision-manufacturing-puerto-rico-l/

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