Atlas FDA

AMO PhacoFlex II Model SI40NB, Intraocular Lenses

FDA device recall Z-1036-03 · posted 2003-07-22 · Terminated

Recall details

Recalling firm
Allergan Medical Optics Inc
Reason for recall
Post operative complaints of cloudiness in the intraocular lenses.
Action taken
Notification letters were sent July 2, 2003 to distributors and subdistributors. Customers were sent letters July 3 and 8, 2003.
Root cause
Other
Status
Terminated
Quantity affected
98
Distribution
Brazil only.
Date initiated
2003-07-02
Date posted
2003-07-22
Date terminated
2004-04-30
Location
Santa Ana, CA

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.