Drug recall
ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random…
FDA recall event 69160 · Class III · Cooper Vision Caribbean Corp.
Key facts
| Event ID | 69160 |
|---|---|
| Recall numbers | Z-0134-2015 |
| Recalling firm | Cooper Vision Caribbean Corp. |
| Product type | Devices |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Sep 17, 2014 |
| Report date | Nov 5, 2014 |
| Termination date | Jun 10, 2015 |
| City | Juana Diaz |
| State | PR |
| Country | United States |
| FEI number | 3002911336 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: