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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81408

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 21, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Johnson & Johnson Surgical Vision Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0464-2019
Recall number
Z-0464-2019
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Quantity
17 IOL's

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Expired intraocular lenses were distributed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Expired intraocular lenses were distributed.

Code information

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.

Distribution pattern

US Nationwide distribution in the states of IN, MN, NC, NV, TX, and WA, WV. There was no foreign/military/government distribution.