Z-2302-2008

Ocular Conformer, Sterile, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265. The device is intended to be...

Name: Z-2302-2008 Ocular Conformer, Sterile, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265. The device is intended to be...
Creator: Porex Surgical, Inc.
Published: 2008-03-28
License: https://open.fda.gov/license/

Porex Surgical, Inc. / initiated 2008-03-28 / Terminated / root cause: manufacturing process

FDA source

Porex Surgical, Inc. began a recall of 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... on 2008-03-28. The reason FDA records is "The Ocular Conformers were distributed with an expired expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2302-2008
Status: Terminated
Initiated: 2008-03-28
Posted: 2008-09-20
Terminated: 2008-10-10
Recalling firm: Porex Surgical, Inc.
Product: 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.
Product code: HQN Conformer, Ophthalmic
Reason for recall: The Ocular Conformers were distributed with an expired expiration date.
Root cause tag: manufacturing process
FDA 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 in commerce: 9 units
Distribution: PA, Canada and Germany
Product codes and lots: Catalog number: 9574, Lot number 001061103C, Catalog number 9548, Lot number 002010204-C, Catalog number 9549, Lot number 003061103C, Catalog number 9779, Lot number 002050804C and Catalog number 9780, Lot number 006101204-C.

Product code HQN

K972034Class IIMedpor Ocular ConformerPorex Surgical, Inc. / cleared 1998-01-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)