| Date Initiated by Firm | November 02, 2005 |
|---|
| Date Posted | November 23, 2005 |
|---|
| Recall Status1 |
Terminated 3 on June 19, 2006 |
| Recall Number | Z-0182-06 |
|---|
| Recall Event ID |
33960 |
| 510(K)Number | K013204 |
|---|
| Product Classification |
Products, Contact Lens Care, Rigid Gas Permeable - Product Code MRC
|
| Product | AQuify Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact Lenses * 1/3 fl. Oz. (10mL) * Sterile * CIBA Vision Corp. Made In Canada Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA |
|---|
| Code Information |
Lot #52246 |
| 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 | Lack of assurance of sterility at the time of manufacture. |
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FDA Determined
Cause 2 | Other |
|---|
| Action | Consignees were contacted by telephone with a follow up letter 11/04/2005. |
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| Quantity in Commerce | 29592 cases (24 units per case) |
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| Distribution | Nationwide, Canada, Germany, Benelux, and the UK |
|---|
| 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 = MRC
|
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