# FDA recall Z-0778-2018

> **Alcon Research, LTD.** · Class II · device recall initiated 2018-01-12.

## Product

Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak    Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.

## Reason for recall

Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOTALPLUS Vitrectomy Pak, instead of a 25+ ULTRAVIT probe.

## Distribution

Worldwide Distribution :  Argentina  Australia  France  Italy  Mexico  Poland  Spain  Sweden  Russia  South Korea  Ukraine

## Key facts

- **Recall number:** Z-0778-2018
- **Recalling firm:** Alcon Research, LTD.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-12
- **Report date:** 2018-03-07
- **Termination date:** 2022-02-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Houston, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0778-2018

## Citation

> AI Analytics. FDA recall Z-0778-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-0778-2018. Source: US FDA. Licensed CC0.

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