CLASS II ONGOING Device recall · Reported 29 Dec 2021 · FDA Enforcement Report
Malosa Core Suface Treatment Pack -Medical Corneal Kit recalled
Beaver Visitec International is recalling Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in, distributed in 9 states. The recall was initiated on 17 Nov 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0406-2022
- FDA event ID
- 89111
- Recalling firm
- Beaver Visitec International, Waltham, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Nov 2021
- FDA classified
- 21 Dec 2021
- Reported
- 29 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 17 Nov 2021 | Recall initiated by company | |
| 21 Dec 2021 | Classified by FDA | +34 days |
| 29 Dec 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Kit packaging may have small holes compromising product sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK110/3
Where it was distributed
CA, CO, LA, MA, MD, ND, PA, TN, UT
CaliforniaColoradoLouisianaMassachusettsMarylandNorth DakotaPennsylvaniaTennesseeUtah
Questions about this recall
Is Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in recalled?
Yes. Beaver Visitec International recalled Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in on 17 Nov 2021. The recall is Class II and its status is Ongoing. Recall number Z-0406-2022.
Why was it recalled?
Kit packaging may have small holes compromising product sterility
Which lots are affected?
Lot Numbers: 3347921, 3358240
Where was it sold?
CA, CO, LA, MA, MD, ND, PA, TN, UT
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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