FDA-Device2021-04-07Class II
Alcon Custom Ophthalmic Surgical Procedure Packs
Alcon Research, LLC
Hazard
Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.
Sold states
Distribution US nationwide, including Puerto Rico; Canada, Australia, New Zealand, Mexico, Malaysia, and Thailand
Affected count
249,853 Custom Packs
Manufactured in
9965 Buffalo Speedway, Houston, TX, United States
Products
Alcon Custom Ophthalmic Surgical Procedure Packs
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1328-2021Don't want to check this manually?
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