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FDA Medical Device Recalls (openFDA)

Ideal Optics, Inc.: 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.

Recall number
Z-0221-05
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.
Status
Terminated
Initiated
2004-10-12
Posted
2004-11-25
Terminated
2006-05-18
Reason
Lenses may not be sterile.
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
1764 vials
Distribution
AL, GA, NC, NY, SC, VA
Lot, serial or model codes
Lot numbers: QG03, QG10, QG19, QH06, QH09, QH14, QI05, QI11, QI20, QJ14, QJ15, QF27, QG29, QI25, QH08 QH22 & SF23
510(k) numbers
not on file
PMA numbers
not on file
Product code
LPL
Firm FEI
1042064
Firm city
Atlanta
Firm state
GA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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