Beaver CustomEyes Cataract Kits with Wrong Blades Recalled
Beaver Visitec recalls CustomEyes cataract surgical kits containing bevel-up blades instead of bevel-down. Affected kits have specific model numbers and lot numbers.
Lower-risk recall
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
Contact the company
What happened, in plain English
Beaver Visitec recalls CustomEyes cataract surgical kits that include a knife with the wrong blade orientation. Using these kits could cause surgical errors if the blade is not properly aligned during surgery. Read more at govinfonow.com/recall/61703-beaver-customeyes-cataract-kits-with-wrong-blades-recalled.
Source Summary by GovInfoNow · govinfonow.com/recall/61703-beaver-customeyes-cataract-kits-with-wrong-blades-recalled · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0229-2022
Cite this page
“Beaver CustomEyes Cataract Kits with Wrong Blades Recalled.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61703-beaver-customeyes-cataract-kits-with-wrong-blades-recalled. Based on FDA recall #Z-0229-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0229-2022%22&limit=1).
Why it’s dangerous
The kits contain blades that are bevel-up instead of the required bevel-down orientation. This could lead to surgical errors if the knife is not properly aligned during cataract surgery.
Who’s affected
Medical professionals using the recalled CustomEyes cataract surgical kits. The risk is low as the hazard is specific to blade orientation during surgery.
How to tell if you have this one
Check for model number REF#373809 and lot numbers 6032947 or 6033588 on the kit packaging. The kits are sold through Lafayette General Medical Center.
- Brand
Beaver Visite: CustomEyes- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan Russia South Africa UK
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0227-2022 | Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809; LOT#: 6000842, 6002045, 6011609, 6034238, 6040517, 6042907. UDI: " Primary: 00886158000594 " Secondary: 30886158000595 " Tertiary: 50886158000599 | 5950 eaches |
| Z-0228-2022 | bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar¿ Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809; Lot Numbers 3296729, 3299124, 3305081, 3307565, 3312464, 3324620, 6033588. UDI: " Primary: 00886158112839 " Secondary: 30886158112830 " Tertiary: 50886158112834 | 500 eaches |
| Z-0229-2022 | bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component REF# 58000572 REF#: 373809; Lot Numbers 6032947 and 6033588 UDI: " Primary: 00886158019961 " Secondary: 30886158019962 " Tertiary: 50886158019966 | 125 eaches |
| Z-0230-2022 | bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for evaluation purposes REF# BVI 58000587; Lot Number 6018382 | 2 units |
What to do — step by step
Check Kit Packaging
Look for model number REF#373809 and lot numbers 6032947 or 6033588 on the kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan Russia South Africa UK” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 47 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
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.
- Official source: FDA Recall #Z-0229-2022 (October 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0229-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.