FDA Enforcement
Class II
Terminated
Healon V, Part No. 10290045
Recall: Z-2067-2017
·
Reported May 17, 2017
Enforcement
- Recall Number
- Z-2067-2017
- Event ID
- 77023
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Abbott Medical Optics Inc. (AMO)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 17, 2017
- Initiation Date
- April 1, 2017
- Classification Date
- May 10, 2017
- Termination Date
- November 27, 2017
- Address
- 1700 E Saint Andrew Pl, N/A, Santa Ana, CA, 92705-4933, United States
Description
Healon V, Part No. 10290045
Reason
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
Code Info
UB32491
Distribution
US and worldwide: Austria Belgium Croatia Czech Republic Denmark Finland France Germany Great Britain Iceland Ireland Israel Italy Latvia Lebanon Lithuania Netherlands Norway Portugal Spain Sweden Switzerland Tunisia Turkey Russian Fed Guadeloupe Sri Lanka Australia China Hong Kong Indonesia Malaysia Singapore South Korea Taiwan Thailand Japan Chile Colombia Costa Rica Ecuador
Quantity
293,867 units total