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.
Recall
- Recall Number
- Z-2302-2008
- Event Number
- 48722
- Firm
- Porex Surgical, Inc.
- FEI Number
- 1000131961
- Product Code
- HQN
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- March 28, 2008
- Posted
- September 20, 2008
- Terminated
- October 10, 2008
- Address
- 15 Dart Rd, Newnan, GA, 30265-1017
Description
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.
The Ocular Conformers were distributed with an expired expiration date.
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.
PA, Canada and Germany
9 units