TEKIA Single Piece Hydrophilic Acrylic Intraocular recall
TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
Why was TEKIA Single Piece Hydrophilic Acrylic Intraocular recalled?
Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
SN: U07310001 thru U07310040 , 07310050 thru U07310059
- Product
- TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
- Recalling firm
- Tekia, Inc.
- Quantity
- 50 units
- Distribution
- Internationally to Vietnam.
- Recall date
- November 18, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)