Recall Z-0907-04 ยท HQC Unit, Phacofragmentation
Allergan Medical Optics Inc
Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40
| Date | Jul 20, 2004 (initiated Mar 29, 2004) |
| Status | Terminated |
| Reason | The lots are being recalled because the tray lid may not be adequately sealed under the red arrow in the upper right corner of the package tray. The blue wrapping within the tray may not be sterile and may pose a potential risk of infection to the patient if used in a sterile field. |
| Root cause | Other |
| Action | On March 31, 2004, a product notification letter was mailed to all customers via certified mail. The customers were instructed to stop using, quarantine and return all units. They were instructed to complete the Facsimile form provided and faxed it to the AMO Customer Service at 888-324-0021. They were also instructed to call AMO Customer Service at 800-366-6554 to make arrangement to return the product. |
| Quantity | 19, 087 |
| Distribution | Distribution was to 67 domestic customers and internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924235 | AMO ELITE Allergan Medical Optics, Dec 23, 1992 |