VISIONAIRE V0200106Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556656532), received between Jun 30, 2022 and Aug 11, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SURGEON PLACED ONE (1) NS VIS ADPT GUIDE GII KIT, AND IT APPEARED TO FIT WELL. AFTER THE DISTAL FEMORAL CUT, THE MEDIAL DISTAL RESECTION SEEMED SMALLER THAN PLANNED. CUT APPROXIMATELY 4MM INSTEAD OF 7.5MM. HE THEN PLACED THE 4-1 BLOCK, AND THE MEDIAL POSTERIOR RESECTION WAS EXCESSIVE, LOOKING TO BE IN EXCESS OF 20MM. THE PROCEDURE WAS RESUMED, AFTER SIGNIFICANT DELAY, BY ADJUSTING MANUALLY THE CUTTING BLOCK TO TRY TO GET APPROPRIATE CUTS. AFTER TRIAL AND ERROR PLACING THE 4-1 BLOCK, THE SURGEON WAS ABLE TO GET IT IN POSITION SO AS NOT TO NOTCH ANTERIORLY AND GET EVEN CUTS POSTERIORLY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE, NO OVERCUTS WERE PERFORMED. PATIENT CURRENT HEALTH STATUS IS RECOVERING AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22778906 ↗
• MalfunctionApr 3, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) NS VIS ADPT GUIDE GII KIT DID NOT FIT PROPERLY AND PRODUCED INSUFFICIENT DISTAL FEMORAL RESECTION. THE PROCEDURE WAS COMPLETED USING INTRAMEDULLARY INSTRUMENTATION AND IT IS UNKNOWN IF THERE WAS ANY DELAY. UNPLANNED EXTRA DISTAL FEMORAL BONE NEEDED TO BE RESECTED, AS WELL AS INTRODUCING INTRAMEDULLARY INSTRUMENTS UP THE FEMORAL CANAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16668683 ↗
• MalfunctionJun 30, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT BOTH GUIDES FROM THE NS VIS ADPT GUIDE GII KIT HAD DEBRIS PRESENT, WHICH WAS DISCOVERED FOLLOWING PROCESSING/STERILIZATION BY THE HOSPITAL. THIS WAS NOTICED UPON INSPECTION; HOWEVER, THE PROCEDURE WAS CONDUCTED WITH THE SAME BLOCKS. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14881431 ↗