CLASS II ONGOING Device recall · Reported 24 Nov 2021 · FDA Enforcement Report
bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr recalled
Beaver Visitec International is recalling bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract, distributed nationwide in the US. The recall was initiated on 8 Oct 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0228-2022
- FDA event ID
- 88826
- Recalling firm
- Beaver Visitec International, Waltham, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Oct 2021
- FDA classified
- 16 Nov 2021
- Reported
- 24 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 8 Oct 2021 | Recall initiated by company | |
| 16 Nov 2021 | Classified by FDA | +39 days |
| 24 Nov 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan Russia South Africa UK
Questions about this recall
Why was it recalled?
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
Which lots are affected?
Lot Numbers 3296729, 3299124, 3305081, 3307565, 3312464, 3324620, 6033588. UDI: " Primary: 00886158112839 " Secondary: 30886158112830 " Tertiary: 50886158112834
Where was it sold?
Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan Russia South Africa UK
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 88826This product is part of a recall event; the main page for the event is bvi CustomEyes Kit-Lafayette General Medical Center recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | bvi CustomEyes Kit-Lafayette General Medical Center recalled | Beaver Visitec International | Packaging Defects | Nationwide | |
| CLASS II | Beaver Xstar Crescent Knife, 55 degrees, bevel down recalled | Beaver Visitec International | Packaging Defects | Nationwide | |
| CLASS II | bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits recalled | Beaver Visitec International | Packaging Defects | Nationwide |
More recalls from Beaver Visitec International
All 194| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BVI Leos Laser and Endoscopy System recalled | Beaver-Visitec International | Manufacturing (CGMP) Deviations | Nationwide |
| Device | CLASS II | BVI CustomEyes Procedure Packs recalled by Beaver Visitec International | Beaver Visitec International | Other | Nationwide |
| Device | CLASS II | BVI CustomEyes Procedure Packs recalled by Beaver Visitec International | Beaver Visitec International | Other | Nationwide |
| Device | CLASS II | BVI CustomEyes Procedure Packs recalled by Beaver Visitec International | Beaver Visitec International | Other | Nationwide |
| Device | CLASS II | BVI CustomEyes Procedure Packs recalled by Beaver Visitec International | Beaver Visitec International | Other | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |