ClearanceBrief
Recall Z-0429-2007 ยท MFK Lens, Multifocal Intraocular

Alcon Laboratories, Inc

AcrySof ReSTOR Intraocular Lens

DateFeb 15, 2007 (initiated Dec 14, 2006)
StatusTerminated
ReasonIntraocular lenses exposed to extreme temperatures while in storage.
Root causeOther
ActionThe recall of the fifteen re-shipped lenses was conducted by telephone calls to the nine customers that had received the lenses. These calls were made on December 14, 2006.
Quantity4 units
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.