Class 2 Device Recall

• Date Initiated by Firm: October 12, 2004
• Date Posted: November 25, 2004
• Recall Status: Terminated 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: 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.