Beaver Visitec recalls Malosa Core SMILE Pack 1 kits with potential packaging holes that could compromise sterility during surgery. Affected units include specific lot numbers for cataract, corneal, and refractive surgery procedures.
Kit packaging may have small holes compromising product sterility
Beaver Visitec is recalling Malosa Core SMILE Pack 1 medical kits used in eye surgery due to possible small holes in the packaging that might allow contamination. This could lead to infections if the kit is used without proper sterility.
The kit packaging may have small holes that could compromise the product's sterility. If the packaging is not sterile, the surgical kit might become contaminated during use, potentially leading to infections in patients.
Surgical teams and medical facilities that purchased the Malosa Core SMILE Pack 1 kits with specific lot numbers listed in the recall. Patients undergoing cataract, corneal, or refractive surgery are at risk if the kit is used without proper sterility.
Check the product label for lot numbers: 3261518, 3272335, 3278550, 3292632, 3305153, 3326272, 3331632, 3334880, 3344465, 3348295, 3350319, 3357568, 3362608, 3363639. The kits are intended for cataract, corneal, or refractive surgery procedures.
Inspect the kit packaging for small holes that could compromise sterility.
Beaver Visitec recalls Malosa Core SMILE Pack 1 medical kits used in cataract, corneal, or refractive surgery due to potential packaging holes that might compromise sterility.
Lot numbers 3261518, 3272335, 3278550, 3292632, 3305153, 3326272, 3331632, 3334880, 3344465, 3348295, 3350319, 3357568, 3362608, 3363639 are affected.
The recall does not specify a stop-use instruction; check for packaging holes and ensure sterility if using the kit.
We’ve drafted a message you can send Beaver Visitec to request your refund or repair — edit it as you like.
Subject: Recall Z-0409-2022 — Beaver Visitec Beaver Visitec Hello, I own a Beaver Visitec that is covered by recall Z-0409-2022 from Beaver Visitec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
