LENS 72204725Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556616727), received between Jun 21, 2018 and Jul 2, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Misfocusing” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE COUPLER FOCUS RING WAS JAMMED. THE PROCEDURE WAS COMPLETED USING THE SAME REPORTED DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391676 ↗
• MalfunctionJun 11, 2025Optical Discoloration; Optical Discoloration

  IT WAS REPORTED THAT DURING SET UP OF THE EQUIPMENT, THE CAMERA COUPLER WAS CONNECTED AND SHOWED A GREEN VIEW. THEY TRIED TO CONNECT AND TEST IT ONCE MORE, OBTAINING THE SAME RESULT. THE PROCEDURE WAS CANCELED AS THERE WAS NO BACKUP DEVICE. THE PATIENT IS STABLE AS THE PROCEDURE WAS RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181696 ↗
• MalfunctionMar 27, 2025Misfocusing; Misfocusing

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE COUPLER COULD NOT FOCUS AND WAS PRODUCING AN UNSATISFACTORY IMAGE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708255 ↗
• MalfunctionNov 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE LENS ADAPTER IS RELEASED FROM THE THREAD OF THE MOUNTED LENS CAMERA HEAD AGAIN AND AGAIN. NO BACKUP DEVICE WAS AVAILABLE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9306939 ↗
• MalfunctionMay 6, 2019Image Display Error/Artifact; Moisture or Humidity Problem

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE COUPLER WAS NOTICED AS FOGGY BECAUSE THERE WAS WATER INSIDE OF THE DEVICE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AS THERE WAS NOT ANY BACK UP DEVICE AVAILABLE. NO PATIENT INJURY OR SIGNIFICANT DELAY WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8584677 ↗
• MalfunctionMar 11, 2019Loose or Intermittent Connection; Misfocusing; Device Fell

  IT WAS REPORTED THAT THE DEVICE WAS FALLING OUT OF FOCUS DUE TO THE COUPLER IS LOOSE. NO PATIENT INJURY WAS REPORTED. A SIGNIFICANT DELAY WAS REPORTED. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8407839 ↗
• MalfunctionFeb 28, 2019Material Opacification

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE DEVICE WAS COMING UP FOGGY. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO PATIENT INJURY REPORTED. A DELAY GREATER THAN 30 MINUTES WAS REPORTED. THERE WAS LOSS OF VISUALIZATION DUE TO THE DEVICE MALFUNCTION AND IT CAUSED THE PATIENT AN EXTENDED EXPOSURE TO ANESTHESIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8379223 ↗
• MalfunctionFeb 22, 2019Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING ROTATOR CUF REPAIR, THE DEVICE WAS FLICKERING. THERE WAS NO DELAY IN THERAPY AND NO BACK-UP WAS AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8363624 ↗
• MalfunctionFeb 14, 2019Noise, Audible

  IT WAS REPORTED THAT THERE IS SOMETHING RATTLING INSIDE THE DEVICE, LIKE A WASHER OR SOMETHING. NO BACKUP WAS AVAILABLE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8339703 ↗
• MalfunctionJun 21, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE THE COUPLER LOCKING IS TOO TIGHT, COUPLER COMES OUT OF CAMERA HEAD WITH ROTATION OF SCOPE. NO BACK-UP DEVICE WAS AVAILABLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7627808 ↗