ClearanceBrief
Recall Z-0987-05 ยท LPN Accessories, Soft Lens Products

Advanced Medical Optics, Inc.

CLARIS Cleaning and Soaking Solution, 4 fl. oz.

DateJul 13, 2005 (initiated Jun 13, 2005)
StatusTerminated
ReasonComponent mix-up of caps/tips. Absence of red tip indicates improperly that the solution is safe for application to the eye.
Root causeOther
ActionFirm intiated recall to distributors on June 13, 2005 by letter.
Quantity32,916
DistributionUndetermined, assumed to be nationwide thru secondary distributors.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.