# FDA recall Z-0354-2023

> **Alcon Research, LLC** · Class II · device recall initiated 2022-10-31.

## Product

Alcon Custom Pak Surgical Procedure Pack

## Reason for recall

Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable.  In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots.

## Distribution

Worldwide Distribution: U.S.(nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and O.U.S. (foreign) to countries of: Australia, Canada, France, Germany, Italy, Mexico, New Zealand, Portugal and United Kingdom.

## Key facts

- **Recall number:** Z-0354-2023
- **Recalling firm:** Alcon Research, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-31
- **Report date:** 2022-12-07

- **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-0354-2023

## Citation

> AI Analytics. FDA recall Z-0354-2023. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0354-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*