Date Initiated by Firm | August 13, 2003 |
Date Posted | September 13, 2003 |
Recall Status1 |
Terminated 3 on January 28, 2005 |
Recall Number | Z-1234-03 |
Recall Event ID |
26932 |
PMA Number | P900029 |
Product Classification |
Accessories, Soft Lens Products - Product Code LPN
|
Product | Quick Care Starting Solution. The product is used for cleaning and disinfection of soft (hydrophilic) contact lenses. |
Code Information |
Lot No. 1278080, exp. date 5/2004 |
Recalling Firm/ Manufacturer |
Ciba Vision Corporation 11440 Johns Creek Parkway Duluth GA 30097
|
For Additional Information Contact | Steve Strouphauer 678-415-3388 |
Manufacturer 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 Determined Cause 2 | 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 |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
PMA Database | PMAs with Product Code = LPN
|