PlainRecalls
FDA Devices Moderate Class II Terminated

Alcon Custom Ophthalmic Surgical Procedure Packs

Reported: April 7, 2021 Initiated: February 2, 2021 #Z-1328-2021

Product Description

Alcon Custom Ophthalmic Surgical Procedure Packs

Reason for Recall

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

Details

Recalling Firm
Alcon Research, LLC
Units Affected
249,853 Custom Packs
Distribution
Distribution US nationwide, including Puerto Rico; Canada, Australia, New Zealand, Mexico, Malaysia, and Thailand
Location
Houston, TX

Frequently Asked Questions

What product was recalled?
Alcon Custom Ophthalmic Surgical Procedure Packs. Recalled by Alcon Research, LLC. Units affected: 249,853 Custom Packs.
Why was this product recalled?
Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 7, 2021. Severity: Moderate. Recall number: Z-1328-2021.