FDA recall Z-0326-2026

Alcon Research LLC · Class II · device

Product

Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

Reason for recall

Potential for a weak seal in some units resulting in compromise in sterility.

Distribution

Worldwide - US distribution in the states of Alabama, Arizona, Arkansas, Connecticut, Florida, Idaho, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oklahoma, Oregon, Tennessee, Texas, Washington and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2025-09-30
Report date
2025-11-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fort Worth, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0326-2026