Recall Z-2302-2008 ยท HQN Conformer, Ophthalmic
Porex Surgical, Inc.
Ocular Conformer, Sterile, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265. The device is intended to be used as a post eye surgery device to prevent closure or adhesion during the healing process.
| Date | Sep 20, 2008 (initiated Mar 28, 2008) |
| Status | Terminated |
| Reason | The Ocular Conformers were distributed with an expired expiration date. |
| Root cause | Employee error |
| Action | Consignees were contacted by phone on 03/28/2008. A follow up letter was sent on/about 03/31/2008. Consignees were instructed to examine their inventory and to quarantine Ocular Conformers containing the affected lots. These units should be returned to Porex Surgical using a Return Authorization Number provided. If the units were distributed, consignees were advised to contact their customers and inform them of the recall. They were informed the recall was being conducted to the physician level. Contact Porex Surgical at 1-770-515-7735 for assistance. |
| Quantity | 9 units |
| Distribution | PA, Canada and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972034 | MEDPOR OCULAR CONFORMER Porex Surgical, Inc., Jan 20, 1998 |