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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 18, 2005
Date Posted August 06, 2005
Recall Status1 Terminated 3 on July 25, 2012
Recall Number Z-1106-05
Recall Event ID 32798
PMA Number P000046 
Product Classification Aid, Surgical, Viscoelastic - Product Code LZP
Product Staarvisic II
Sodium Hyaluronate, 0.8 mL
Code Information Lot B041118C Exp Date 12/31/2005
Recalling Firm/
Staar Surgical Co Inc
1911 Walker Ave
Monrovia CA 91016-4846
For Additional Information Contact Valerie Cimmarusti
Manufacturer Reason
for Recall
Sterility may be compromised.
FDA Determined
Cause 2
Action Recall will be communicated by telephone, email and letter. A fax back form will be used to track response and to identify ammount on hand.
Quantity in Commerce 16,464
Distribution Nationwide, Canada and Puerto Rico
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.
PMA Database PMAs with Product Code = LZP and Original Applicant = Anika Therapeutics, Inc.