# FDA recall Z-1373-2022

> **Alcon Research, LLC** · Class II · device recall initiated 2022-06-09.

## Product

Alcon Custom Pak Surgical Procedure Pack:  16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP    18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE    18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS    11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR    11802-07 14LTRW GANS BASIC PACK NOVAMED EYE SURG CTR    11802-07 14LLME GANS BASIC PACK NOVAMED EYE SURG CTR    14429-07 14HPW3 DR SIEMINSKI CATARACT W NY CTR/AMB SVCS

## Reason for recall

Due to latex gloves being include in Custom Pak.  Kits are supposed to include non-latex gloves.

## Distribution

U.S.: AZ, CA, MO, and NY    O.U.S.: None

## Key facts

- **Recall number:** Z-1373-2022
- **Recalling firm:** Alcon Research, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-09
- **Report date:** 2022-07-20

- **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-1373-2022

## Citation

> AI Analytics. FDA recall Z-1373-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1373-2022. Source: US FDA. Licensed CC0.

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