Visitec® 585159Recalls & reported problems
Beaver-Visitec International, Inc. · ACM Micro Etched [Dahan] .90 x 4mm (20G x 5/32in) 45 Degree beveled tip · Class 1
All models of Visitec (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30886158101988), received between Apr 29, 2024 and Apr 29, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
IN REFERENCE TO (B)(4), CUSTOMER ALLEGED THAT A SURGEON WAS USING A THE CORTICAL CLEAVING HYDRODISSECTOR (BOLGER) 50X22MM, 25G X7/8 (33DEGREE) BY BVI VISITEC LOT 3465442 EXP 29/02/2028 REF 585159 DURING SURGERY. THE DEVICE WAS IN TACT WHEN OPENED AND WAS USED ONCE AND UPON THE SECOND INSERTION TO THE EYE THE DEVICE WAS NOT CONNECTED LEAVING THE METAL PART IN-SITU OF THE EYE. THE SURGEON RETRIEVED THIS WITH SOME FORCEPS WITH NO FURTHER COMPLICATIONS. A NEW DEVICE OF A DIFFERENT BATCH WAS THEN USED WITH NO PROBLEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19210151 ↗
Other Cannula, Ophthalmic devices
- iTrack Advance iTrack-ADSNova Eye, Inc. · Cannula, Ophthalmic53 reports
- iTrack 250ANova Eye, Inc. · Cannula, Ophthalmic1 recall2 reports
- Vortex Surgical Inc VS0200.25Vortex Surgical, Inc. · Cannula, Ophthalmic1 recall0 reports
- Vortex Surgical Inc VS0275.27Vortex Surgical, Inc. · Cannula, Ophthalmic1 recall0 reports
- Vortex Surgical Inc VS0220.25Vortex Surgical, Inc. · Cannula, Ophthalmic1 recall0 reports
- Visitec® 585278Beaver-Visitec International, Inc. · Cannula, Ophthalmic1 recall0 reports
- Vortex Surgical Inc VS0205.23Vortex Surgical, Inc. · Cannula, Ophthalmic1 recall0 reports
- Vortex Surgical Inc VS0250.25Vortex Surgical, Inc. · Cannula, Ophthalmic1 recall0 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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