FDA-Device2021-12-29Class II

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

Beaver Visitec International, Inc.
Hazard

Kit packaging may have small holes compromising product sterility

Sold states
CA, CO, LA, MA, MD, ND, PA, TN, UT
Affected count
680 units
Manufactured in
500 Totten Pond Rd, 10 City Point, Waltham, MA, United States
Products
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0409-2022

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