# FDA recall Z-1291-2023

> **Alcon Research, LLC** · Class II · device recall initiated 2023-03-10.

## Product

Alcon Custom Pak Surgical Procedure Pack:  Pak Number & Pak Description:  17533-04	DR GROSS LPS LLC  18704-03	CATARACT SURGI CARE  18382-03	DR GEORGE ZAMBELLI BEAVER VALLEY ASC  8685-21	CATARACT PACK EYE SURGICAL CNTR OF AR  19451-02	DR ROESKE PACK INLAND VALLEY SURGERY CTR  19136-03	OCCULOPLASTIC WILMINGTON EYE  18401-03	MCGRAW SIGHTPATH MEDICAL  16032-05	MIDDLE TENNESSEE PACK SIGHTPATH MEDICAL  17570-05	CATARACT CENTURION FORT MADISON COMM HOS  19002-02	CATARACT BAPTIST HEALTH SURGERY CENTER  10560-14	CATARACT - NORTH CENTRAL 1 SIGHTPATH MED  16877-11	DR DAVID B LEACH CLEARVIEW SURGERY CENTE  19061-02	HOSLER UNIVERSITY SURGI CENTER  18911-02	MASON CATARACT THE ASC AT UNITED MEDICAL  17469-02	GENERAL CUSTOM PACK SHARP MEMORIAL HOSPI  18917-01	CATARACT 2 SURGERY CENTER OF THE TEMECUL  17115-06	DR SCZEPANSKI NORTH DAKOTA EYE CLINIC  17780-04	OPHTHALMIC TEXAS PRECISION SURGERY CENTE  2452-58	CATARACT BOLSA OUTPATIENT SURG CTR  19096-01	OPHTHALMIC EAST ALABAMA AMB SURGERY CENT  18023-04	O

## Reason for recall

Sterility; Steril surgical procedure packs contain incomplete seals.

## Distribution

US: AL, AR, CA, IA, ID, IN, KY, MN, NC, ND, NJ, OH, PA, TX,  OUS: None

## Key facts

- **Recall number:** Z-1291-2023
- **Recalling firm:** Alcon Research, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-10
- **Report date:** 2023-04-05

- **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-1291-2023

## Citation

> AI Analytics. FDA recall Z-1291-2023. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1291-2023. Source: US FDA. Licensed CC0.

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