Z-0221-05

IDEAL SOFT (polymacon) Hydrophic contact lens, 62% poly (2-hydroxyethlymethacrytate). 38% water immersed in...

Name: Z-0221-05 IDEAL SOFT (polymacon) Hydrophic contact lens, 62% poly (2-hydroxyethlymethacrytate). 38% water immersed in...
Creator: Ideal Optics, Inc.
Published: 2004-10-12
License: https://open.fda.gov/license/

Ideal Optics, Inc. / initiated 2004-10-12 / Terminated / root cause: sterility

FDA source

Ideal Optics, Inc. began a recall of IDEAL SOFT (polymacon) Hydrophic contact lens, 62% poly (2-hydroxyethlymethacrytate). 38% water immersed in 0.9% sodium chloride solution. One sterile... on 2004-10-12. The reason FDA records is "Lenses may not be sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0221-05
Status: Terminated
Initiated: 2004-10-12
Posted: 2004-11-25
Terminated: 2006-05-18
Recalling firm: Ideal Optics, Inc.
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.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: Lenses may not be sterile.
Root cause tag: sterility
FDA root 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
Product codes and lots: Lot numbers: QG03, QG10, QG19, QH06, QH09, QH14, QI05, QI11, QI20, QJ14, QJ15, QF27, QG29, QI25, QH08 QH22 & SF23

Product code LPL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)