Date Initiated by Firm |
July 25, 2006 |
Date Posted |
August 16, 2006 |
Recall Status1 |
Terminated 3 on December 27, 2006 |
Recall Number |
Z-1402-06 |
Recall Event ID |
35990 |
510(K)Number |
K050065
|
Product Classification |
Soft contact lenses - Product Code LPL
|
Product |
Focus¿ * DAILIES¿ * Toric * One-Day Contact Lenses * CIBA Vision |
Code Information |
Lot #6118348 (5 pack), 6110170 (30 pack) and 6110210 (30 pack) |
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 |
Misbranding; Lenses (-0.75) are labeled with the incorrect power of (-1.50) .
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by letter on/about 07/25/06 to return any of the affected lots found in inventory |
Quantity in Commerce |
86 (approx 1000 lenses) packs total |
Distribution |
Nationwide including the states of CA, HI, IL, MA, MI, NE, NJ, NY, OH, TX, UT, VA, WA. |
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.
|
510(K) Database |
510(K)s with Product Code = LPL and Original Applicant = CIBA VISION CORPORATION
|