Beaver Visitec recalls cataract surgical kits containing non-sterile sample knives that have bevel-up blades instead of bevel-down. Affected kits include REF# BVI 58000587, Lot 6018382.
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
Beaver Visitec is recalling cataract surgical kits that contain a non-sterile sample knife with bevel-up blades instead of the required bevel-down blades. This could lead to improper surgical procedures if used in actual surgery.
The knives in the recalled kits have bevel-up blades instead of the required bevel-down blades. This design difference could cause improper cutting during surgical procedures if mistakenly used in actual surgery.
Surgical teams using the recalled kits for evaluation purposes, not for actual surgery. The risk is low since these are non-sterile samples for testing only.
Check for the product name 'CustomEyes Kit-CustomEyes Cataract Surgical Kits' with reference number BVI 58000587 and lot number 6018382. These kits contain a non-sterile sample knife.
Verify the reference number and lot number on the kit packaging to confirm if it's affected.
No, these kits contain non-sterile sample knives with bevel-up blades, which are not intended for actual surgery.
The official recall notice does not specify a remedy for the recalled kits.
The kits contain non-sterile sample knives with bevel-up blades instead of the required bevel-down blades.
We’ve drafted a message you can send Beaver Visitec to request your refund or repair — edit it as you like.
Subject: Recall Z-0230-2022 — Beaver Visitec Beaver Visitec Hello, I own a Beaver Visitec that is covered by recall Z-0230-2022 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.
