Z-0464-2019Class II

Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00...

Name: Z-0464-2019 Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00...
Creator: Johnson & Johnson Surgical Vision Inc
Published: 2018-06-21
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2018-06-21 / Terminated / root cause: manufacturing process

FDA source

Johnson & Johnson Surgical Vision Inc began a recall of Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are... on 2018-06-21. FDA classified it as Class II and gives the reason as "Expired intraocular lenses were distributed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0464-2019
Classification: Class II
Status: Terminated
Initiated: 2018-06-21
Posted: 2018-11-14
Terminated: 2021-04-28
Recalling firm: Advanced Medical Optics, Inc.
Product: 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.
Product code: HQL Intraocular Lens
Reason for recall: Expired intraocular lenses were distributed.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm issued letters dated 6/21/2018 via Federal Express requesting return of the IOL's.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0464-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0464-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-14

Product code HQL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)