| |
Class 2 Device Recall |
 |
| Date Initiated by Firm |
October 12, 2004 |
| Date Posted |
November 25, 2004 |
| Recall Status1 |
Terminated 3 on May 18, 2006 |
| Recall Number |
Z-0221-05 |
| Recall Event ID |
30310 |
| Product Classification |
Lenses, Soft Contact, Daily Wear - Product Code LPL
|
| Product |
IDEAL SOFT¿ (polymacon) Hydrophic contact lens, 62% poly (2-hydroxyethlymethacrytate). 38% water immersed in 0.9% sodium chloride solution. One sterile, Manufactured by: Ideal Optics, Inc., Atlanta, GA 30339. |
| Code Information |
Lot numbers: QG03, QG10, QG19, QH06, QH09, QH14, QI05, QI11, QI20, QJ14, QJ15, QF27, QG29, QI25, QH08 QH22 & SF23 |
Recalling Firm/
Manufacturer |
Ideal Optics, Inc.
2255 Cumberland Pkwy Se Ste 500
Atlanta GA 30339-4524
|
| For Additional Information Contact |
Jay C. Garmon, Jr.
770-432-0048
|
Manufacturer Reason
for Recall |
Lenses may not be sterile.
|
FDA Determined
Cause 2 |
Other |
| Action |
Consignees were notified by letter on 10/13/2004. A second letter was sent out on 11/8/2004 with addtional lots. |
| Quantity in Commerce |
1764 vials |
| Distribution |
AL, GA, NC, NY, SC, VA |
| 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.
|
|
|
|
