Reported Dec 29, 2021 · Ongoing
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery.…
Beaver Visitec International, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beaver Visitec International, Inc. · 500 Totten Pond Rd · Waltham, MA · 02451-1916
Is this the product you have?
- Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery
- Part NumberMMK884
- Lot codes and dates
- Lot Numbers
32615183272335327855032926323305153332627233316323334880334446533482953350319335756833626083363639
- Lot Numbers
- Amount recalled
- 680 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Kit packaging may have small holes compromising product sterility
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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