ProClear Toric contact lenses are made from a material containing 62%… — Class III medical device recall Z-0134-2015
Terminated recall by Cooper Vision Caribbean Corp., reported 2014-11-05, distributed nationwide. Routine quality monitoring system has identified that a limited number of lots were manufactured with the cyli
| Recall number | Z-0134-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cooper Vision Caribbean Corp., Juana Diaz, PR, United States |
| Recall initiated | 2014-09-17 |
| Classified | 2014-10-24 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2015-06-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| UPC / GTIN / UDI-DI | 10002500013006, 10011500013008, 10014500017007, 10015550005006, 10033550003006, 10043550006006, 10052550006008, 10053550012006, 10077500031008, 10086500022008, 10113500023008, 10147500019006, 10148500021006, 10154550000007, 10193500014008, 10218500014008, 10218500018006, 10220500022006, 10245500023006, 10263500018006, 10427500016022, 10429500018006, 10430500016022, 10430550002006 |
Product
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.
Reason for recall
Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0134-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.