Z-0237-2016 Class II Terminated
FDA device recall Z-0237-2016 was initiated by Tekia, Inc. on September 29, 2015 and is designated Class II. Reason for recall: Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power. The recall status is terminated (terminated December 3, 2015). Affected quantity: 50 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 18, 2015
- Initiation Date
- September 29, 2015
- Termination Date
- December 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
Reason for Recall
Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.
Distribution Pattern
Internationally to Vietnam.
Code Information
SN: U07310001 thru U07310040 , 07310050 thru U07310059