Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1234-03

Quick Care Starting Solution. The product is used for cleaning and disinfection of soft (hydrophilic) contact...

Alcon Laboratories / initiated 2003-08-13 / Terminated

Ciba Vision Corporation began a recall of Quick Care Starting Solution. The product is used for cleaning and disinfection of soft (hydrophilic) contact lenses on . The reason FDA records is "Investigation has determined that the concentration of the isopropyl alcohol (IPA) decreased over time and may fall below specifications prior to reaching the expiration date". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1234-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Alcon Laboratories
Product
Quick Care Starting Solution. The product is used for cleaning and disinfection of soft (hydrophilic) contact lenses.
Product code
LPN Accessories, Soft Lens Products
Reason for recall
Investigation has determined that the concentration of the isopropyl alcohol (IPA) decreased over time and may fall below specifications prior to reaching the expiration date.
FDA root cause
Other
Action
The consignees were notified of the recall by letter on August 13, 2003 asking for return of the product.
Quantity in commerce
2,136 units
Distribution
CA, CT, FL, GA, IA, KS, MI, MN, OH, and WI
Product codes and lots
Lot No. 1278080, exp. date 5/2004