Recall Z-1911-2009 ยท HQL Intraocular Lens
Bausch & Lomb Inc
Adapt AO, Akreos Advanced Optics Aspheric Lens. Bausch & Lomb Incorporated, Rochester, NY. Manufactured by Bausch & Lomb Incorporated, Clearwater, FL.
| Date | Sep 9, 2009 (initiated Dec 8, 2008) |
| Status | Terminated |
| Reason | Affected lenses were inadvertently shipped to Bausch & Lomb's European Logistics Center (ELC) prior to release authorization. Initial testing indicated the product did not meet release criteria for endotoxin limits. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | All consignees were notified via phone, telefax and letter. Products are to be returned to Bausch & Lomb's European Logistics Center (ELC) for destruction. Direct questions to Bausch and Lomb, Inc. by calling 1-585-338-6612. |
| Quantity | 158 |
| Distribution | Foreign Distribution only -- Algeria, Belgium, Bulgaria, Croatia, Germany, Hungary, Ireland, Israel, Italy, Mexico, Portugal, Spain, Thailand and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.