FDA Recall
Terminated
FreshLook ColorBlends, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH -5.25, LOT ***, 2006-08, CIBA VISION Corporation, A Novartis Company, Duluth, GA 30007, USA, Made in USA. Product is packed in 6 packs.
Recall: Z-0740-04
·
Initiated March 11, 2004
Recall
- Recall Number
- Z-0740-04
- Event Number
- 28542
- Firm
- Ciba Vision Corporation
- FEI Number
- 1053053
- Product Code
- LPM
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 11, 2004
- Posted
- July 20, 2004
- Terminated
- November 16, 2005
- Address
- 11440 Johns Creek Pkwy, Duluth, GA, 30097-1518
Description
FreshLook ColorBlends, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH -5.25, LOT ***, 2006-08, CIBA VISION Corporation, A Novartis Company, Duluth, GA 30007, USA, Made in USA. Product is packed in 6 packs.
Reason
The lens inside the package does not match the prescription information labeled on the primary package.
Action
Consignees were notified by letter on 3/11/2004.
Distribution
Nationwide, Canada, Latin America, South America, Germany, Thailand and South Africa.
Quantity
4461/6pk