FDA recall Z-1328-2021

Alcon Research, LLC · Class II · device

Product

Alcon Custom Ophthalmic Surgical Procedure Packs

Reason for recall

Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.

Distribution

Distribution US nationwide, including Puerto Rico; Canada, Australia, New Zealand, Mexico, Malaysia, and Thailand

Key facts

Status
Terminated
Initiation date
2021-02-02
Report date
2021-04-07
Termination date
2023-06-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1328-2021