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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 January 06, 2004
Date Posted January 29, 2004
Recall Status1 Terminated 3 on January 04, 2005
Recall Number Z-0378-04
Recall Event ID 28070
Product Classification Lens, Guide, Intraocular - Product Code KYB
Product MicroSTAAR Injector Cartridges Models:

SFC-25 (utilized with plate haptic Collamer lens)
MTC-60 (utilized with plate haptic Silicone lens)
Code Information SFC-25 (8 lots) 1180608, 1181078, 1181170,1181171, 1181396, 1181397, 1182237, 1184864 MTC-60 (25 lots) 1177222, 1177950, 1178121, 1178212, 1176868, 1177421, 1178738, 1178883, 1178885, 1179023, 1181789, 1181790, 1181797, 1181798, 1181980, 1182245, 1182342, 1182343, 1182344, 1182345, 1182675, 1182676, 1182677, 1182761.
Recalling Firm/
Manufacturer		 Staar Surgical Co Inc
1911 Walker Ave
Monrovia CA 91016-4846
For Additional Information Contact Jason K. Lyon
626-303-7902 Ext. 2273
Manufacturer Reason
for Recall		 Increased numbers of lens tears during placement of lens into eye.
FDA Determined
Cause 2		 Other
Action Customers will recieve recall notice, Customer Bulletin and MicroStaar Injector Cartridge Guide by Federal Espress (sent 1/6/04).
Distribution Nationwide, Canada and Australia
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.
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