FDA Enforcement
Class II
Terminated
SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
Recall: Z-2860-2016
·
Reported September 28, 2016
Enforcement
- Recall Number
- Z-2860-2016
- Event ID
- 75051
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Abbott Medical Optics Inc. (AMO)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 28, 2016
- Initiation Date
- August 26, 2016
- Classification Date
- September 21, 2016
- Termination Date
- December 23, 2016
- Address
- 1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933, United States
Description
SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
Reason
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Code Info
Serial No. 5050941602
Distribution
Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
Quantity
1 unit