Device product
TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
Z-0237-2016
Product summary
- Firm
- Tekia, Inc.
- Event
- Event 72434
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 units
- Official record key
device-enforcement:Z-0237-2016
Official wording
Reason: Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.
Code information: SN: U07310001 thru U07310040 , 07310050 thru U07310059
Distribution pattern: Internationally to Vietnam.
Derived failure modes
-
Unknown
Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.