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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
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/
Ideal Optics, Inc.
2255 Cumberland Pkwy Se Ste 500
Atlanta GA 30339-4524
For Additional Information Contact Jay C. Garmon, Jr.
Manufacturer Reason
for Recall
Lenses may not be sterile.
FDA Determined
Cause 2
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.