VISIONAIRE V0100020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556076958), received between Mar 1, 2021 and Mar 1, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Fitting Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 1, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE FEMUR BLOCK DIDN¿T FIT AND THE SURGEON HAD TO CONVERT TO STANDARD INSTRUMENTS. ACCORDING TO THE SALES REP, WHEN DR. (B)(6)PUSHED DOWN THE DISTAL MEDIAL PADDLE, IT CAME OFF DISTAL LATERAL BONE AND VICE VERSA. HE ALSO SAID THE BLOCK "DIDN¿T HAVE THE TYPICAL HOOK FEEL". INSTRUMENTS WERE INSIDE THE PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY. 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 11391116 ↗