Data Foundry

Medical device recalls 2021

TECNIS Toric 1-Piece IOL — Class II medical device recall Z-1163-2021

Terminated recall by Johnson & Johnson Surgical Vision Inc, reported 2021-03-10, distributed nationwide. Due to the release of nonconforming Intraocular Lenses (IOLs).

Recall numberZ-1163-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmJohnson & Johnson Surgical Vision Inc, Santa Ana, CA, United States
Recall initiated2021-01-27
Classified2021-03-03
Reported by FDA2021-03-10
Terminated2022-11-09
DistributedNationwide (US)
Quantity27 lenses
UPC / GTIN / UDI-DI05050474552210
Lot numbers8144121847
Model numbers1.50DCYL, ZCT150

Product

TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.

Reason for recall

Due to the release of nonconforming Intraocular Lenses (IOLs).

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1163-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.