Z-2067-2017 Class II Terminated
FDA device recall Z-2067-2017 was initiated by Abbott Medical Optics Inc. (AMO) on April 1, 2017 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated November 27, 2017). Affected quantity: 293,867 units total.
Recall Details
- Product Type
- Devices
- Report Date
- May 17, 2017
- Initiation Date
- April 1, 2017
- Termination Date
- November 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 293,867 units total
Product Description
Reason for Recall
Distribution Pattern
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