FDA recall Z-0406-2022

Beaver Visitec International, Inc. · Class II · device

Product

Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK110/3

Reason for recall

Kit packaging may have small holes compromising product sterility

Distribution

CA, CO, LA, MA, MD, ND, PA, TN, UT

Key facts

Status
Ongoing
Initiation date
2021-11-17
Report date
2021-12-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0406-2022