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Class 2 Device Recall |
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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
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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
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For Additional Information Contact |
Jason K. Lyon 626-303-7902 Ext. 2273
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Manufacturer Reason for Recall |
Increased numbers of lens tears during placement of lens into eye.
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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
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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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