Malosa Core LASIK Pack Recalled for Sterility-Compromising Packaging Defects
Beaver Visitec International recalls 920 units of Malosa Core LASIK Pack due to packaging holes that may compromise product sterility. Compromised sterility creates infection risk in surgical use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a sterility-compromising packaging defect in surgical equipment. No illnesses or injuries have been reported, but the defect poses a theoretical infection risk during eye surgery, meeting the criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Beaver Visitec International, Inc. is recalling 920 units of the Malosa Core LASIK Pack 2-Medical Refractive Kit (Part Number MMK100/2), which is intended to aid in cataract, corneal, and refractive eye surgery.
The kits are being recalled because the packaging may have small holes that compromise the product's sterility. In surgical applications, compromised sterility creates a risk of contamination and infection.
The affected kits were distributed to medical facilities in California, Colorado, Louisiana, Massachusetts, Maryland, North Dakota, Pennsylvania, Tennessee, and Utah. The affected lot numbers are 3309015, 3347920, 3351630, 3356836, 3360219, and 3364419.
Healthcare providers who have received these kits should contact Beaver Visitec International, Inc. for guidance regarding the affected units.
The recalled product
- Product
- Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2
- Manufacturer
- Beaver Visitec International, Inc.
- Affected units
- 920
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot Numbers: 3309015
- 3347920
- 3351630
- 3356836
- 3360219
- 3364419
Distribution
Part of a larger recall action
This product is one of 6 recalled by Beaver Visitec International, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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