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U.S. Department of Health and Human Services

Class 2 Device Recall CIBASoft Visitint

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 Class 2 Recall
CIBASoft Visitint
see related information
Date Posted May 09, 2007
Recall Status1 Terminated on March 13, 2008
Recall Number Z-0793-2007
Recall Event ID 37854
Premarket Approval
PMA Number
P820086
Product Classification Lenses, Soft Contact, Daily Wear - 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/
Manufacturer
Ciba Vision Corporation
11460 Johns Creek Pkwy
Duluth, Georgia 30097-1518
For Additional Information Contact Gina Ingraham
678-415-4088
Manufacturer Reason
for Recall
Base curve of the lenses do not meet specification.
FDA Determined
Cause 2
TRAINING: Employee Error
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LPL and Applicant = CIBA VISION CARE
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