Recall Z-0237-2016— Tekia, Inc.
Class II · Terminated
Class II FDA medical device recall by Tekia, Inc., initiated 2015-09-29, terminated 2015-12-03. FDA's recall record names no specific 510(k) clearance for this event. Product: TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811. Reason: Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power..
- Recalling firm
- Tekia, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-29
- Terminated
- 2015-12-03
- Firm location
- Irvine, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.