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U.S. Department of Health and Human Services

Class 2 Device Recall Soft Contact Lens

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  Class 2 Device Recall Soft Contact Lens see related information
Date Initiated by Firm December 09, 2004
Date Posted December 23, 2004
Recall Status1 Terminated 3 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
Recalling Firm/
Ocular Sciences, Inc.
6815 Academy Parkway W NE
Albuquerque NM 87109-4405
For Additional Information Contact Mr. Michael Briggs
Manufacturer Reason
for Recall
Vials containing the lenses are possibly contaminated with residual hydrogen peroxide.
FDA Determined
Cause 2
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 and Original Applicant = SUNSOFT CORP.