FDA Recall
Terminated
AMO PhacoFlex II Model SI40NB, Intraocular Lenses
Recall: Z-1036-03
·
Initiated July 2, 2003
Recall
- Recall Number
- Z-1036-03
- Event Number
- 26712
- Firm
- Allergan Medical Optics Inc
- FEI Number
- 3003843509
- Status
- Terminated
- Root Cause
- Other
- Initiated
- July 2, 2003
- Posted
- July 22, 2003
- Terminated
- April 30, 2004
- Address
- 1700 E. St.Andrew Place, Santa Ana, CA, 92799
Description
AMO PhacoFlex II Model SI40NB, Intraocular Lenses
Reason
Post operative complaints of cloudiness in the intraocular lenses.
Action
Notification letters were sent July 2, 2003 to distributors and subdistributors. Customers were sent letters July 3 and 8, 2003.
Distribution
Brazil only.
Quantity
98