FDAClass IIDecember 29, 2021

Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical recall: Sterility Concern

Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number…

Why was Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical recalled?

Kit packaging may have small holes compromising product sterility

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 3347922, 3350452, 3354937, 3358047, 3364371

Product
Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number…
Recalling firm
Beaver Visitec International, Inc.
Quantity
1170 units
Distribution
CA, CO, LA, MA, MD, ND, PA, TN, UT
Recall date
December 29, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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