Z-0740-04
FreshLook ColorBlends, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile...
Alcon Laboratories / initiated 2004-03-11 / Terminated / root cause: labeling and UDI
Ciba Vision Corporation began a recall of FreshLook ColorBlends, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH -5.25, LOT ***, 2006-08, CIBA VISION... on . The reason FDA records is "The lens inside the package does not match the prescription information labeled on the primary package". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0740-04
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Alcon Laboratories
- Product
- 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.
- Product code
- LPM Lenses, Soft Contact, Extended Wear
- Reason for recall
- The lens inside the package does not match the prescription information labeled on the primary package.
- Root cause tag
- labeling and UDI
- FDA root cause
- Other
- Action
- Consignees were notified by letter on 3/11/2004.
- Quantity in commerce
- 4461/6pk
- Distribution
- Nationwide, Canada, Latin America, South America, Germany, Thailand and South Africa.
- Product codes and lots
- Lot #063302, Exp. Date: 2006-08, Lot #088472, Exp. Date: 2008-07, Lot #073059, Exp. Date 2008-02, Lot #074338, Exp. Date: 2008-02.
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