CustomEyes® 58001973Recalls & reported problems
Beaver-Visitec International, Inc. · CUSTOMEYES KIT 58001973 (1/EA) · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jul 26, 2024Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
Z-2931-2024 · Root cause: No Marketing Application · FDA record ↗
Other Kit, surgical instrument, disposable devices
- Medline Industries, Inc. DYNJ83185AMedline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- CustomEyes® 58001713Beaver-Visitec International, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Medline Industries, Inc. DYNJ69761Medline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Synergetics 18069WSynergetics USA, Inc. · Kit, Surgical Instrument, Disposable2 recalls0 reports
- Synergetics 18060Synergetics USA, Inc. · Kit, Surgical Instrument, Disposable2 recalls0 reports
- Medline Industries, Inc. DYNJ68217AMedline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Medline Industries, Inc. DYNJ80200BMedline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Medline Industries, Inc. DYNJ39461JMedline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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