Atlas FDA

AQuify Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact Lenses * 1/3 fl. Oz. (10mL) * Ste

FDA device recall Z-0182-06 · posted 2005-11-23 · Terminated

Recall details

Recalling firm
Ciba Vision Corporation
Reason for recall
Lack of assurance of sterility at the time of manufacture.
Action taken
Consignees were contacted by telephone with a follow up letter 11/04/2005.
Root cause
Other
Status
Terminated
Product code
MRC
Quantity affected
29592 cases (24 units per case)
Distribution
Nationwide, Canada, Germany, Benelux, and the UK
Date initiated
2005-11-02
Date posted
2005-11-23
Date terminated
2006-06-19
Location
Duluth, GA

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Related 510(k) clearances

RecordFirmDate
AQUIFY LENS COMFORT DROPS (K013204)Ciba Vision Corporation2002-04-03