ClearanceBrief
Recall Z-1036-03 ยท

Allergan Medical Optics Inc

AMO PhacoFlex II Model SI40NB, Intraocular Lenses

DateJul 22, 2003 (initiated Jul 2, 2003)
StatusTerminated
ReasonPost operative complaints of cloudiness in the intraocular lenses.
Root causeOther
ActionNotification letters were sent July 2, 2003 to distributors and subdistributors. Customers were sent letters July 3 and 8, 2003.
Quantity98
DistributionBrazil only.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.