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 2 Device Recall CSI Daily wear

  • 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 2 Device Recall CSI Daily wearsee related information
Date Initiated by FirmSeptember 13, 2006
Date PostedNovember 04, 2006
Recall Status1 Terminated 3 on February 28, 2009
Recall NumberZ-0018-07
Recall Event ID 36382
Product Classification Contact lenses - Product Code LPL
ProductCSI Daily Wear, soft (hydrophilic) contact lenses
Code Information Polymer Lot #RM-309824, RM-309691, RM-309631, RM-309592, 03D0201, 03D1401, RM-309825, RM-309762
FEI Number 1053053
Recalling Firm/
Manufacturer		 Ciba Vision Corporation
11460 Johns Creek Pkwy
Duluth GA 30097-1518
For Additional Information ContactGina Ingraham
678-415-4088
Manufacturer Reason
for Recall		Out of specification lens curve
FDA Determined
Cause 2		Other
ActionConsignees were notified via traceable mail on 09/13/2006.
Quantity in Commerce42,075 units
DistributionWorldwide-U.S., Canada, Australia and Barbados.
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.
-
-