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FDA Medical Device Recalls (openFDA)

Ciba Vision Corporation: AQuify Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact Lenses * 1/3 fl. Oz. (10mL) * Sterile * CIBA Vision Corp. Made In Canada Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA

Recall number
Z-0182-06
Recalling firm
Ciba Vision Corporation
Product
AQuify Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact Lenses * 1/3 fl. Oz. (10mL) * Sterile * CIBA Vision Corp. Made In Canada Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA
Status
Terminated
Initiated
2005-11-02
Posted
2005-11-23
Terminated
2006-06-19
Reason
Lack of assurance of sterility at the time of manufacture.
Root cause
Other
Action
Consignees were contacted by telephone with a follow up letter 11/04/2005.
Quantity
29592 cases (24 units per case)
Distribution
Nationwide, Canada, Germany, Benelux, and the UK
Lot, serial or model codes
Lot #52246
510(k) numbers
["K013204"]
PMA numbers
not on file
Product code
MRC
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

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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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