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.
FDA Recall Z-2302-2008 · Posted 2008-09-20
Recalling FirmPorex Surgical, Inc.
Recall StatusTerminated
Product CodeHQN
Date Initiated2008-03-28
Date Terminated2008-10-10
Product Quantity9 units
Reason for Recall
The Ocular Conformers were distributed with an expired expiration date.
Firm 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.
Root Cause
Employee error
Distribution Pattern
PA, Canada and Germany
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.