ClearanceBrief
Recall Z-0182-06 ยท MRC Products, Contact Lens Care, Rigid Gas Permeable

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

DateNov 23, 2005 (initiated Nov 2, 2005)
StatusTerminated
ReasonLack of assurance of sterility at the time of manufacture.
Root causeOther
ActionConsignees were contacted by telephone with a follow up letter 11/04/2005.
Quantity29592 cases (24 units per case)
DistributionNationwide, Canada, Germany, Benelux, and the UK
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K013204AQUIFY LENS COMFORT DROPS
Ciba Vision Corporation, Apr 3, 2002