VisionPro 0240031020Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613327056082), received between Mar 2, 2020 and Sep 22, 2023 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17800795 ↗
• MalfunctionAug 24, 2023Device Fell; Device Fell

  IT WAS REPORTED THAT THE MONITOR FELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17611504 ↗
• MalfunctionNov 18, 2021No Display/Image; Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE DURING PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12838991 ↗
• MalfunctionAug 17, 2020No Display/Image; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF ADVERSE CONSEQUENCES, MEDICAL INTERVENTION OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10414579 ↗
• InjuryMar 18, 2020Display Difficult to Read; Display Difficult to Read

  IT WAS REPORTED THAT THERE WAS LOSS OF VISUALIZATION DURING PROCEDURE, CAUSING GALLBLADDER INJURY AND SURGICAL DELAY GREATER THAN 30 MINUTES.

  Patient problems: Injury

  MAUDE report 9850483 ↗
• MalfunctionMar 2, 2020No Display/Image; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9777520 ↗
• MalfunctionMar 2, 2020No Display/Image; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9777519 ↗
• MalfunctionMar 2, 2020No Display/Image; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9777518 ↗
• MalfunctionMar 2, 2020No Display/Image; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9777517 ↗
• MalfunctionMar 2, 2020No Display/Image; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9777516 ↗
• MalfunctionMar 2, 2020No Display/Image; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9777484 ↗
• MalfunctionMar 2, 2020No Display/Image; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9777483 ↗
• MalfunctionMar 2, 2020No Display/Image; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9777482 ↗
• MalfunctionMar 2, 2020No Display/Image; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9777481 ↗
• MalfunctionMar 2, 2020No Display/Image; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9777480 ↗
• MalfunctionMar 2, 2020No Display/Image; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9775877 ↗