Class 3 Device Recall Alcon/Grieshaber Morris ILM Forceps, Direct Action

• Date Initiated by Firm: March 07, 2008
• Date Posted: May 14, 2008
• Recall Status: Terminated on July 18, 2008
• Recall Number: Z-1461-2008
• Recall Event ID: 47401
• Product Classification: Manual ophthalmic surgical instrument - Product Code HNR
• Product: Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number: 641.22; Non-sterile/Reusable; Alcon Laboratories, Inc., Fort Worth, TX 76134.
• Code Information: Lot Numbers: F58834, F60464, F60465 and F60466.
• Recalling Firm/ Manufacturer: Alcon Research, Ltd; 6201 South Fwy; Fort Worth TX 76134-2001
• For Additional Information Contact: 817-551-6813
• Manufacturer Reason for Recall: Device corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction.
• FDA Determined Cause: Device Design
• Action: Consignees were notified by an Urgent Medical Device Recall that was sent via fax on 03/07/08. Users were instructed to cease using the affected products and to return a Recall Acknowledgement Form to the recalling firm. The sales representative will pick up the affected product and discuss replacement alternatives. For additional information, contact 1-800-757-9780.
• Quantity in Commerce: 24 units
• Distribution: Nationwide Distribution including states of AL and CA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.