Cataract Surgery Kits Recalled for Compromised Sterile Packaging
Beaver Visitec is recalling Malosa Core Phaco Pack 1 cataract surgery kits (Part Number: MMK833/2) because packaging may have small holes that compromise product sterility. The recall affects 120 units distributed across nine states.
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: This FDA Class II medical device recall involves surgical instruments with packaging that may compromise sterility. While no illnesses or injuries have been reported, there is an inherent risk of harm if contaminated instruments are used in eye surgery, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beaver Visitec International, Inc. is recalling the Malosa Core Phaco Pack 1-Medical Cataract Kit (Part Number: MMK833/2), a surgical instrument kit intended to aid in cataract, corneal, or refractive surgery.
The recall was initiated because the kit packaging may contain small holes that compromise the product's sterility. Compromised packaging exposes surgical instruments to potential contamination during storage or handling, which is critical for instruments used in sterile surgical procedures.
The recall affects 120 units distributed to medical facilities in California, Colorado, Louisiana, Massachusetts, Maryland, North Dakota, Pennsylvania, Tennessee, and Utah. The affected lot numbers are 3272267, 3274728, and 3323887.
Healthcare providers should discontinue use of affected kits immediately and contact Beaver Visitec International, Inc. for return instructions and replacement kits. Do not use any kits from the identified lot numbers in surgical procedures.
The recalled product
- Product
- Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2
- Manufacturer
- Beaver Visitec International, Inc.
- Affected units
- 120
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 (3)
- Lot Numbers: 3272267
- 3274728
- 3323887
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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