VISIONAIRE V0200013Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556583036), received between Nov 21, 2019 and Oct 19, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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.

• MalfunctionOct 19, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, BEFORE A TKA SURGERY, THE SURGEON WAS NOT PLEASED THE PRE-OP PLAN BECAUSE WANTED TO UPSIZE THE FEMUR, BUT THIS HAS NOT BEEN ADJUSTED IN THE PRE-OP PLAN, AND THE NON STERILE VISIONAIRE RIGHT CUTTING BLOCK KIT - GENESIS II WAS ALREADY SHIPPED. IT IS NEEDED TO SOLVE THIS ISSUE FAST, THE PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656781 ↗
• MalfunctionNov 21, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PROCEDURE BLOCK DID NOT FIT PROPERLY ON THE MEDIAL CONDYLE OF THE FEMUR AND WHEN PINNED CAUSED THE ROTATION TO BE THROWN OFF. STANDARD INSTRUMENTATION AVAILABLE AND USED. NO INJURIES OR DELAYS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9359291 ↗