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FDA Medical Device Recalls (openFDA)

Ciba Vision Corporation: FreshLook Colors, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH ***, LOT ***, 2006-11, CIBA VISION Corporation, A Novartis Company, Duluth, GA 30007, USA, Made in USA.6-pack, 2 pack and single trial. Product is packed in 6 packs, 2 packs and single trial packs (Samples not for sale)

Recall number
Z-0741-04
Recalling firm
Ciba Vision Corporation
Product
FreshLook Colors, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH ***, LOT ***, 2006-11, CIBA VISION Corporation, A Novartis Company, Duluth, GA 30007, USA, Made in USA.6-pack, 2 pack and single trial. Product is packed in 6 packs, 2 packs and single trial packs (Samples not for sale)
Status
Terminated
Initiated
2004-03-11
Posted
2004-07-20
Terminated
2005-11-16
Reason
The lens inside the package does not match the prescription information labeled on the primary package.
Root cause
Other
Action
Consignees were notified by letter on 3/11/2004.
Quantity
3141/6pk, 1000/2pk & 1720/single trial
Distribution
Nationwide, Canada, Latin America, South America, Germany, Thailand and South Africa.
Lot, serial or model codes
Lot #067121, Exp. Date 2006-11, Lot #065047, Exp. Date 2006-11, Lot #065530, Exp. Date 2006-11, Lot #079803, Exp. Date 2003-08, Lot #065310, Exp. Date: 2006-11, Lot #0-65427, Exp. Date: 2006-11.
510(k) numbers
not on file
PMA numbers
not on file
Product code
LPM
Firm FEI
1053053
Firm city
Duluth
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

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

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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