Medical Refractive Surgery Kit Recalled for Sterility-Compromising Packaging Defects
Beaver Visitec is recalling 1,170 units of its Malosa Core SMILE Pack 2 surgical refractive kit because packaging may contain small holes that could compromise sterility. Affected units were distributed across nine states.
What this means for you
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 medical device recall. No illnesses or injuries have been reported. The hazard—potential sterility compromise from packaging holes—presents a theoretical risk to patient safety during surgery, but the risk has not yet materialized in reported cases.
Plain-English summary
Beaver Visitec International, Inc. is recalling 1,170 units of the Malosa Core SMILE Pack 2 medical refractive kit (Part Number MMK967), a device intended to aid in cataract, corneal, or refractive surgery.
The recalled kits have packaging that may contain small holes, which could compromise the sterility of the surgical instruments inside. Sterility is critical for surgical instruments to prevent infection.
The affected units were distributed in the following states: California, Colorado, Louisiana, Massachusetts, Maryland, North Dakota, Pennsylvania, Tennessee, and Utah. They can be identified by the following lot numbers: 3347922, 3350452, 3354937, 3358047, and 3364371. If you have received any of these kits, contact Beaver Visitec International, Inc. for instructions on how to proceed.
The recalled product
- Product
- Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK967
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- sterility-compromise
- packaging-defect
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 (5)
- Lot Numbers: 3347922
- 3350452
- 3354937
- 3358047
- 3364371
Distribution
Distributed in 9 states:
- CA
- CO
- LA
- MA
- MD
- ND
- PA
- TN
- UT
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