Beaver Visitec International, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0410-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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: MMK967

Product Classification:

Class II

Date Initiated: November 17, 2021

Date Posted: December 29, 2021

Recall Number: Z-0410-2022

Event ID: 89111

Reason for Recall:

Kit packaging may have small holes compromising product sterility

Status: Ongoing

Product Quantity: 1170 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated