Beaver Visitec International, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0409-2022)

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

Product Classification:

Class II

Date Initiated: November 17, 2021

Date Posted: December 29, 2021

Recall Number: Z-0409-2022

Event ID: 89111

Reason for Recall:

Kit packaging may have small holes compromising product sterility

Status: Ongoing

Product Quantity: 680 units

Code Information:

Lot Numbers: 3261518, 3272335, 3278550, 3292632, 3305153, 3326272, 3331632, 3334880, 3344465, 3348295, 3350319, 3357568, 3362608, 3363639

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated