COOPERVISION Manufacturing Puerto Rico, LLC
Juana Diaz, PR, US
COOPERVISION Manufacturing Puerto Rico, LLC appears in FDA device records in Juana Diaz, PR. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to COOPERVISION Manufacturing Puerto Rico, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Cooper Vision Caribbean Corp.enforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2640128 | 3002911336 | COOPERVISION Manufacturing Puerto Rico, LLC | 500 ROAD 584, LOT 7, Juana Diaz, PR 00795 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0529-2015 | Soft Contact Lens | Portions of the lots may contain units with an incorrect lens axis condition. | Class II | Terminated | |
| Z-0134-2015 | 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 to make the lens more visible for handling. | Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification. | Class III | Terminated | |
| Z-0631-2013 | AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses | The lenses exceeded the acceptance limit for silicone oil residual. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets COOPERVISION Manufacturing Puerto Rico, LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain