FDA Devices Moderate Class II Ongoing

Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2

Reported: December 29, 2021 Initiated: November 17, 2021 #Z-0405-2022

Product Description

Reason for Recall

Kit packaging may have small holes compromising product sterility

Details

Recalling Firm: Beaver Visitec International, Inc.
Units Affected: 920 units
Distribution: CA, CO, LA, MA, MD, ND, PA, TN, UT
Location: Waltham, MA

Frequently Asked Questions

What product was recalled? ▼

Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2. Recalled by Beaver Visitec International, Inc.. Units affected: 920 units.

Why was this product recalled? ▼

Kit packaging may have small holes compromising product sterility

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on December 29, 2021. Severity: Moderate. Recall number: Z-0405-2022.

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