# FDA recall Z-0464-2019

> **Johnson & Johnson Surgical Vision Inc** · Class II · device recall initiated 2018-06-21.

## 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.

## Reason for recall

Expired intraocular lenses were distributed.

## Distribution

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

## Key facts

- **Recall number:** Z-0464-2019
- **Recalling firm:** Johnson & Johnson Surgical Vision Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-21
- **Report date:** 2018-11-21
- **Termination date:** 2021-04-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Ana, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0464-2019

## Citation

> AI Analytics. FDA recall Z-0464-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0464-2019. Source: US FDA. Licensed CC0.

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