Reported Nov 21, 2018 · Terminated
Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile,…
Johnson & Johnson Surgical Vision Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Johnson & Johnson Surgical Vision Inc · 1700 E Saint Andrew Pl · Santa Ana, CA · 92705-4933
Is this the product you have?
- Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile
- Rx - Product UsageThe lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag
- Lot codes and dates
17 of 17 products
Products covered by this recall Model / number Barcodes Product as published PCB000505047455845829.5D, Ser. #3496431503, exp. 3/11/2018, UDI (01)05050474558458(17)180311(21)3496431503 PCB000505047455807610.5D, Ser. #4824531411, exp. 10/9/2017, UDI (01)05050474558076(17)171009(21)4824531411 PCB000505047455809011.5D, Ser. #2354451505, exp. 5/7/2018, UDI (01)05050474558090(17)180507(21)2354451505 PCB000505047455810612.0D, Ser. #3595511502, exp. 2/14/2018, UDI (01)05050474558106(17)180214(21)3595511502 PCB000505047455810612.0D, Ser. #3595551502, exp. 2/14/2018, UDI (01)05050474558106(17)180214(21)3595551502 PCB000505047455811312.5D, Ser. #3488131502, exp. 2/13/2018, UDI (01)05050474558113(17)180213(21)3488131502 PCB000505047455812013.0D, Ser. #5435161502, exp. 2/26/2018, UDI (01)05050474558120(17)180226(21)5435161502 PCB000505047455812013.0D, Ser. #5435261502, exp. 2/26/2018, UDI (01)05050474558120(17)180226(21)5435261502 PCB000505047455813713.5D, Ser. #3004621502, exp. 2/10/2018, UDI (01)05050474558137(17)180210(21)3004621502 PCB000505047455814414.0D, Ser. #3242641504, exp. 4/13/2018, UDI (01)05050474558144(17)180413(21)3242641504 PCB000505047455814414.0D, Ser. #6356451503, exp. 3/31/2018, UDI (01)05050474558144(17)180331(21)6356451503 PCB000505047455815114.5D, Ser. #2212331502, exp. 2/3/2018, UDI (01)05050474558151(17)180203(21)2212331502 PCB000505047455817515.5D, Ser. #2577541505, exp. 5/11/2018, UDI (01)05050474558175(17)180511(21)2577541505 PCB000505047455841027.5D, Ser. #2173131504, exp. 4/2/2018, UDI (01)05050474558410(17)180402(21)2173131504 PCB000505047455843428.5D, Ser. #3526291503, exp. 3/11/2018, UDI (01)05050474558434(17)180311(21)3526291503 PCB000505047455844129.0D, Ser. #3224481503, exp. 3/10/2018, UDI (01)05050474558441(17)180310(21)3224481503 PCB0005050474558465and 30.0D, Ser. #3989691502, exp. 2/17/2018, UDI (01)05050474558465(17)180217(21)3989691502. - Amount recalled
- 17 IOL's
Where it was sold
Why it was recalled
Expired intraocular lenses were distributed.
This product could cause temporary or reversible health problems — stop using it.
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