Recall Z-0095-06 ยท HQL Intraocular Lens
Advanced Medical Optics, Inc.
CeeOn EDGE Silicone Posterior Chamber IOLs (Modelsl 911A and 913A)
| Date | Oct 28, 2005 (initiated Oct 5, 2005) |
| Status | Terminated |
| Reason | A small opening (channel or tunnel) in the seal of the outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery. |
| Root cause | Other |
| Action | A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated. |
| Quantity | 292 (28 in US) |
| Distribution | Nationwide, Austria, Belgium, Switzerland, Germany, Denmark, France, UK, Guadelope, Hong Kong, Croatia, India, Italy, Netherlands, and Vietnam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.