Surgical Corneal Kit Packaging May Compromise Product Sterility
Beaver Visitec is recalling the Malosa Core Surface Treatment Pack surgical kit because packaging may have holes that compromise sterility during eye procedures.
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 is an FDA Class II recall of a surgical medical device. Although no illnesses or injuries have been reported, compromised sterility in eye surgery instruments presents a risk of serious infection. Per the rubric, risk-of-harm products without reported injury receive a High severity rating.
Plain-English summary
Beaver Visitec International, Inc., is recalling the Malosa Core Surface Treatment Pack, a medical corneal kit used to aid in cataract, corneal, and refractive eye surgery. The recalled product is Part Number MMK110/3, in Lot Numbers 3347921 and 3358240.
The kit packaging may contain small holes that compromise the sterility of the product. Compromised sterility in surgical kits used during eye procedures presents a risk of infection.
Approximately 380 units were distributed to healthcare facilities in California, Colorado, Louisiana, Massachusetts, Maryland, North Dakota, Pennsylvania, Tennessee, and Utah.
Surgical facilities and eye care providers who received this product should cease use immediately and contact Beaver Visitec International, Inc., for return or replacement instructions.
The recalled product
- Product
- Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK110/3
- Manufacturer
- Beaver Visitec International, Inc.
- Affected units
- 380
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 (2)
- Lot Numbers: 3347921
- 3358240
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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