Class 2 Device Recall Soft Contact Lens

• Date Initiated by Firm: December 09, 2004
• Date Posted: December 23, 2004
• Recall Status: Terminated on March 31, 2005
• Recall Number: Z-0348-05
• Recall Event ID: 30647
• 510(K)Number: K964696
• Product Classification: Lenses, Soft Contact, Daily Wear - Product Code LPL
• Product: Sunsoft Multiples Toric, methafilcon A, clear contact lens.
• Code Information: Lot Number 12981729
• FEI Number: 1629558
• Recalling Firm/ Manufacturer: Ocular Sciences, Inc.; 6815 Academy Parkway W NE; Albuquerque NM 87109-4405
• For Additional Information Contact: Mr. Michael Briggs; 505-345-7967
• Manufacturer Reason for Recall: Vials containing the lenses are possibly contaminated with residual hydrogen peroxide.
• FDA Determined Cause: Other
• Action: All consignees were notified by courier on 12/09/2004.
• Quantity in Commerce: 46 lenses
• Distribution: AR, AZ, CA, DC, GA, MI, MO, MS, NJ, NM, OR, PA, TN, TX, WI. No government, military or foreign distribution.
• 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.

• 510(K) Database: 510(K)s with Product Code = LPL