VISIONAIRE V0100108Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556656389), received between Mar 15, 2021 and Jun 29, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Align” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING TKA SURGERY, A VIS ADPT GUIDE LGNP FEM WAS DOWN FITTING WELL, BUT THE ALIGNMENT WAS VERY LATERAL. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. SURGERY WAS LESS THAN OR EQUAL TO 30MINS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085972 ↗
• MalfunctionMar 15, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT DURING A TKA, WHEN SURGEON PLACED THE VIS ADPT GUIDE LGNP TIB WITH ALIGNMENT ROD. PADDLES WERE NOT SITTING CORRECTLY. THEY WERE NOT FLUSH ON THE TIBIA PLATEAUS. SLOPE APPEARED TO BE AT 0 DEGREES WHEN PLANNED FOR 3 DEGREES. INSTRUMENTS INSIDE PATIENT, PROCEDURE FINISHED WITH SAME DEVICE. SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11479249 ↗