VisitecRecalls & reported problems across all models
Beaver-Visitec International, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Visitec model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 3 models of Visitec by Beaver-Visitec International, Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Apr 28, 2023 and Apr 29, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (3 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Visitec recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 25, 2022Open, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1626-2022 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported Visitec problems
Device problems
- Contamination /Decontamination Problem3
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Visitec models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Visitec® 585278Cannula, Ophthalmic1 recall0 reports
- Visitec® 585282Cannula, Ophthalmic3 reports
- Visitec® 585159Cannula, Ophthalmic1 report
Recent Visitec adverse event reports
The 4 most recent reports across all models, 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 ↗MalfunctionApr 28, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
CUSTOMER COMPLAINED OF A COATING FOUND ON THE CANNULA. (1 OF 2).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16840395 ↗MalfunctionApr 28, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
CUSTOMER REPORTED THAT "CONTAMINATION AND MISSING EXPIRY DATE HAS BEEN IDENTIFIED WITHIN BATCH DURING INCOMING INSPECTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16840391 ↗MalfunctionApr 28, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
CUSTOMER COMPLAINED OF A COATING FOUND ON THE CANNULA. (2 OF 2).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16840390 ↗
Other Beaver-Visitec International, Inc. products
All Beaver-Visitec International, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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