| Class 2 Device Recall | |
Date Initiated by Firm | April 21, 2005 |
Create Date | June 25, 2015 |
Recall Status1 |
Terminated 3 on October 21, 2005 |
Recall Number | Z-0847-05 |
Recall Event ID |
31864 |
Product Classification |
Lenses, Soft Contact, Daily Wear - Product Code LPL
|
Product | Fresh Look * Radiance * Moonlight, (phemfilcon) Contact Lenses * -2.75 median, Median Dia:14.5 * Rx only * Ciba Vision, Duluth, GA. The product has been distributed in twin packs containing six pairs of lenses. |
Code Information |
Lot #124637 |
Recalling Firm/ Manufacturer |
Ciba Vision Corporation 11460 Johns Creek Pkwy Duluth GA 30097-1518
|
For Additional Information Contact | Gina Ingraham 678-415-4088 |
Manufacturer Reason for Recall | The actual power of the lenses may be different from what is indicated on the package labeling. |
FDA Determined Cause 2 | Other |
Action | Consignees were notified via traceable mail on April 21, 2005. |
Quantity in Commerce | 2250 units |
Distribution | Nationwide, Europe |
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.
|
|
|
|