Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the recall
Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses…
Why was Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the recalled?
Expired intraocular lenses were distributed.
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?
Item PCB00 29.5D, Ser. #3496431503, exp. 3/11/2018, UDI (01)05050474558458(17)180311(21)3496431503; Item PCB00 10.5D, Ser. #4824531411, exp. 10/9/2017, UDI (01)05050474558076(17)171009(21)4824531411; Item PCB00 11.5D, Ser. #2354451505, exp. 5/7/2018, UDI (01)05050474558090(17)180507(21)2354451505; Item PCB00 12.0D, Ser. #3595511502, exp. 2/14/2018, UDI (01)05050474558106(17)180214(21)3595511502; Item PCB00 12.0D, Ser. #3595551502, exp. 2/14/2018, UDI (01)05050474558106(17)180214(21)3595551502; Item PCB00 12.5D, Ser. #3488131502, exp. 2/13/2018, UDI (01)05050474558113(17)180213(21)3488131502; Item PCB00 13.0D, Ser. #5435161502, exp. 2/26/2018, UDI (01)05050474558120(17)180226(21)5435161502; Item PCB00 13.0D, Ser. #5435261502, exp. 2/26/2018, UDI (01)05050474558120(17)180226(21)5435261502; Item PCB00 13.5D, Ser. #3004621502, exp. 2/10/2018, UDI (01)05050474558137(17)180210(21)3004621502; Item PCB00 14.0D, Ser. #3242641504, exp. 4/13/2018, UDI (01)05050474558144(17)180413(21)3242641504; Item PCB00 14.0D, Ser. #6356451503, exp. 3/31/2018, UDI (01)05050474558144(17)180331(21)6356451503; Item PCB00 14.5D, Ser. #2212331502, exp. 2/3/2018, UDI (01)05050474558151(17)180203(21)2212331502; Item PCB00 15.5D, Ser. #2577541505, exp. 5/11/2018, UDI (01)05050474558175(17)180511(21)2577541505; Item PCB00 27.5D, Ser. #2173131504, exp. 4/2/2018, UDI (01)05050474558410(17)180402(21)2173131504; Item PCB00 28.5D, Ser. #3526291503, exp. 3/11/2018, UDI (01)05050474558434(17)180311(21)3526291503; Item PCB00 29.0D, Ser. #3224481503, exp. 3/10/2018, UDI (01)05050474558441(17)180310(21)3224481503; and Item PCB00 30.0D, Ser. #3989691502, exp. 2/17/2018, UDI (01)05050474558465(17)180217(21)3989691502.
- Product
- Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses…
- Recalling firm
- Johnson & Johnson Surgical Vision Inc
- Quantity
- 17 IOL's
- Distribution
- US Nationwide distribution in the states of IN, MN, NC, NV, TX, and WA, WV. There was no foreign/military/government distribution.
- Recall date
- November 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)