Atlas FDA

CIBASoft Visitint Soft Contact Lenses, SKU #749591001385, Power -6.50, Diameter 13.8, Base Curve, 8.9, Expiration 2011-1

FDA device recall Z-0793-2007 · posted 2007-05-09 · Terminated

Recall details

Recalling firm
Ciba Vision Corporation
Reason for recall
Base curve of the lenses do not meet specification.
Action taken
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.
Root cause
Other
Status
Terminated
Product code
LPL
Quantity affected
22 lenses
Distribution
Nationwide.
Date initiated
2007-04-30
Date posted
2007-05-09
Date terminated
2008-03-13
Location
Duluth, GA

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