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U.S. Department of Health and Human Services

Class 2 Device Recall CIBASoft Visitint

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  Class 2 Device Recall CIBASoft Visitint see related information
Date Initiated by Firm April 30, 2007
Date Posted May 09, 2007
Recall Status1 Terminated 3 on March 13, 2008
Recall Number Z-0793-2007
Recall Event ID 37854
PMA Number P820086 
Product Classification Soft Contact Lenses - Product Code LPL
Product CIBASoft¿ Visitint Soft Contact Lenses, SKU #749591001385, Power -6.50, Diameter 13.8, Base Curve, 8.9, Expiration 2011-10.
Code Information Lot #41074100201110
Recalling Firm/
Ciba Vision Corporation
11460 Johns Creek Pkwy
Duluth GA 30097-1518
For Additional Information Contact Gina Ingraham
Manufacturer Reason
for Recall
Base curve of the lenses do not meet specification.
FDA Determined
Cause 2
Action Consignees were contacted via traceable mail on 4/30/2007. The initial notification was sent to Eye Care Professionals. The firm subsequently identified one distributor and one retailer. The recall letter was revised and sent to these consignees on May 2, 2007. Specific return instructions were attached along with a Recall Tracking Form that was to be completed and returned to CIBA Vision. They were instructed to return any of the affected product on hand to CIBA Vision for replacement.
Quantity in Commerce 22 lenses
Distribution Nationwide.
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 = LPL and Original Applicant = CIBA VISION CARE