Data / Medical devices / United States / COOPERVISION Manufacturing Puerto Rico, LLC
COOPERVISION Manufacturing Puerto Rico, LLC: FDA-registered device maker in Juana Diaz, PR, United States, 10 510(k) clearances and 2 PMA approvals
COOPERVISION Manufacturing Puerto Rico, LLC is registered with the FDA (registration 2640128) in Juana Diaz, PR, United States. It lists 3 device types. The FDA files 10 510(k) clearances and 2 PMA approvals under its listings, the newest dated February 4, 2022. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2640128
- FEI number
- 3002911336
- Address
- 500 Road 584, Lot 7 Amuelas Industrial Park, Juana Diaz, PR, United States, 00795
- Owner or operator
- COOPERVISION, INC. (9929062)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- April 27, 2006
- Registered through
- 2026
- Brand names listed
- Avaira Vitality Sphere, Avaira Vitality Toric, BIOFINITY MULTIFOCAL, BIOFINITY TORIC, BIOFINITY TORIC MULTIFOCAL, BIOFINITY XR, Biofinity, Biofinity Energys and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Extended Wear | LPM | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 4, 2022 | K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| October 26, 2021 | K213164 | Avaira Vitality | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| April 29, 2019 | K190965 | MyDay | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| July 13, 2016 | K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| August 30, 2013 | K131378 | SUS (STENFILCON A) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| January 5, 2010 | K091339 | BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| November 22, 2006 | K061948 | PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS | MVN | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| December 6, 2005 | K052560 | BIOFINITY (COMFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| January 21, 1999 | K984046 | BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS | LPL | Substantially Equivalent | Ocular Sciences Puerto Rico, Inc. | accessdata.fda.gov |
| August 20, 1997 | K972303 | OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS | LPL | Substantially Equivalent | Ocular Sciences Puerto Rico, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 19, 2008 | P080011 | BIOFINITY (COMFILCON A) | LPM | 201 | September 2, 2026 | accessdata.fda.gov |
| September 19, 1989 | P890023 | H55 HYDROPHILIC CONTACT LENS | LPM | 53 | December 11, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 28, 2014 | 69496 | Class II | Terminated | Soft Contact Lens | Portions of the lots may contain units with an incorrect lens axis condition. | accessdata.fda.gov |
| September 17, 2014 | 69160 | Class III | Terminated | ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added t | Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification. | accessdata.fda.gov |
| November 9, 2012 | 63719 | Class II | Terminated | AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses | The lenses exceeded the acceptance limit for silicone oil residual. | accessdata.fda.gov |
Compare with other makers
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lens, Contact, (Disposable)
- All makers of Lenses, Soft Contact, Extended Wear
Updated September 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.