Events

Recall of Device Recall Ocular Conformer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Porex Surgical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    48722
  • Event Risk Class
    Class 3
  • Event Number
    Z-2302-2008
  • Event Initiated Date
    2008-03-28
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72000
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Conformer, ophthalmic - Product Code HQN
  • Reason
    The ocular conformers were distributed with an expired expiration date.
  • 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.

Device

Device Recall Ocular Conformer
  • Model / Serial
    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 Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    PA, Canada and Germany
  • Product 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.
  • Manufacturer
    Porex Surgical, Inc.

Manufacturer

Porex Surgical, Inc.
  • Manufacturer Address
    Porex Surgical, Inc., 15 Dart Rd, Newnan GA 30265-1017
  • Source
    USFDA