CLASS II Device recall · Reported 21 Nov 2018 · FDA Enforcement Report
Abbott Tecnis 1-Piece Aspheric Acrylic Iol recalled
Johnson & Johnson Surgical Vision is recalling Abbott Tecnis 1-Piece Aspheric Acrylic Iol with the Tecnis iTEC Preloaded Delivery System, distributed nationwide in the US. The recall was initiated on 21 Jun 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0464-2019
- FDA event ID
- 81408
- Recalling firm
- Johnson & Johnson Surgical Vision, Santa Ana, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jun 2018
- FDA classified
- 14 Nov 2018
- Reported
- 21 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Contact Lenses & Eye Devices
Timeline
| 21 Jun 2018 | Recall initiated by company | |
| 14 Nov 2018 | Classified by FDA | +146 days |
| 21 Nov 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Expired intraocular lenses were distributed.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The 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.
Where it was distributed
US Nationwide distribution in the states of IN, MN, NC, NV, TX, and WA, WV. There was no foreign/military/government distribution.
Nationwide MinnesotaNorth CarolinaNevadaTexasWashingtonWest Virginia
Questions about this recall
Is Abbott Tecnis 1-Piece Aspheric Acrylic Iol with the Tecnis iTEC Preloaded Delivery System recalled?
Yes. Johnson & Johnson Surgical Vision recalled Abbott Tecnis 1-Piece Aspheric Acrylic Iol with the Tecnis iTEC Preloaded Delivery System on 21 Jun 2018. The recall is Class II and its status is Terminated. Recall number Z-0464-2019.
Why was it recalled?
Expired intraocular lenses were distributed.
Which lots 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.
Where was it sold?
US Nationwide distribution in the states of IN, MN, NC, NV, TX, and WA, WV. There was no foreign/military/government distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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