| 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) |
| FEI Number |
1053053
|
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
|
|---|
