Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recallsee related information
Date Initiated by FirmFebruary 23, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on January 04, 2005
Recall NumberZ-0766-04
Recall Event ID 28570
Product Classification Lens, Guide, Intraocular - Product Code KYB
ProductMicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF
Code Information Lot 11853090.   Sterility Date : 11/18/2003 Expiration Date: 10/31/2006
Recalling Firm/
Manufacturer		 Staar Surgical Co Inc
1911 Walker Ave
Monrovia CA 91016-4846
For Additional Information ContactJanice L. Filippelli
626-303-7902 Ext. 2345
Manufacturer Reason
for Recall		Injector mold design/manufacture and wear caused material flash to develop preventing assembly of the device prior to use.
FDA Determined
Cause 2		Other
ActionFirm will be sending thier representatives to customers to inspect inventory and arrange return of product.
Quantity in Commerce690 injectors
DistributionNationwide.
Total Product Life CycleTPLC 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.
-
-