FDANovember 17, 2021device

Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Kit packaging may have small holes compromising product sterility

What to do

FDA enforcement status: Ongoing

Brands named

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Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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