LENS 72203967SRecalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 00885556631980), received between Jan 29, 2018 and Jan 7, 2026 — classified as 94 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (60 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 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Overheating of Device

  IT WAS REPORTED THAT THE CAMERA HEAD WAS GETTING VERY HOT. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY, IF THERE WAS PATIENT INVOLVEMENT, IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996311 ↗
• MalfunctionDec 28, 2022Optical Discoloration; Optical Discoloration

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE CAMERA HEAD HAD BLUE SCREEN, THE PATIENT WAS ALREADY ANESTHETIZED WHEN THE PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE. THERE WAS A SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061315 ↗
• MalfunctionDec 28, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE CAMERA HEAD WAS WARM WHEN USE. IT IS UNKNOWN WHEN THE EVENT HAPPENED RELATIVE TO SURGERY. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061234 ↗
• MalfunctionJun 22, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING USE, THE CAMERA HEAD WAS GETTING HOT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14778184 ↗
• MalfunctionJul 20, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING USE, OUTSIDE THE PATIENT, THE CAMERA HEAD LENS INT SYS HAS BLACK SCREEN. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12198041 ↗
• MalfunctionJul 8, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE CAMERA HEAD WAS ABNORMALLY HOT . NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139043 ↗
• MalfunctionJun 23, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT. THE CAMERA HEAD LENS HAD A BAD CONNECTION. IT IS UNKNOWN IF THE EVENT OCCURRED DURING SURGERY, IF THERE WAS A BACKUP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12048969 ↗
• MalfunctionJun 18, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT, DURING SURGERY, THE "CAMERA HEAD" WON'T TURN ON/OFF. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WERE NO PROCEDURAL DELAYS AND NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12026267 ↗
• MalfunctionJun 7, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION, THE CAMERA HEAD WAS NOT WORKING PROPERLY. CONNECTION WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO DELAY AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952783 ↗
• MalfunctionJun 3, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING THE SET UP OF AN UNKNOWN PROCEDURE, THE CAMERA HEAD DID NOT SHOW THE PICTURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11929014 ↗
• MalfunctionJun 2, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE CAMERA HEAD LENS WAS NOT WORKING, THE IMAGE WAS POOR AND IT COULD NOT TAKE PICTURES. THE INCIDENT OCCURRED BEFORE THE PROCEDURE. THERE WAS NO DELAY AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11920686 ↗
• MalfunctionMay 25, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE, INSIDE THE PATIENT, THE IMAGE OF THE CAMERA HEAD LENS INT SYS DISAPPEARED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11879337 ↗
• MalfunctionMay 24, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A KNEE SCOPE THE CAMERA HEAD'S SCREEN TURNED PINK AND IT WENT BLACK DOWN. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO INJURIES, DELAYS OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872652 ↗
• MalfunctionMay 19, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT CANNOT SEE THROUGH THE CAMERA HEAD. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850788 ↗
• MalfunctionMay 1, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING THE SURGERY THE PICTURE WAS LOST ON THE CAMERA HEAD. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK UP DEVICE WAS USED TO COMPLETE THE SURGERY. 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 11758664 ↗
• MalfunctionApr 26, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT, DURING THE SET-UP OF AN UNKNOWN PROCEDURE, THE SERVICE REPL CAMERA HEAD LENS INT SYS WAS NOT WORKING. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD LOSS OF IMAGE WHEN THE CABLE IS FLEXED NEAR THE STAIN RELIEF WHICH MAKES IT A REPORTABLE EVENT. 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 11729401 ↗
• MalfunctionApr 19, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SCREEN OF THE CAMERA HEAD WAS SHOWING PURPLE QUEUE. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED, HOW THE PROCEDURE WAS FINISHED, AND IF A DELAY OCCURRED. HOWEVER, NO PATIENT INJURIES WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD LOSS OF IMAGE WHICH MAKES IT A REPORTABLE EVENT. 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 11686458 ↗
• MalfunctionApr 15, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE CAMERA (CAMERA HEAD LENS INT SYS) IS GRAINY AND SOMETIMES SHOWS A COLORED BLOCK SPLIT SCREEN. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED. 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 11675815 ↗
• MalfunctionApr 6, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT SUDDENLY, THE CAMERA HEAD SWITCHED IMAGE TO A COLOR BAR. INCIDENT OCCURRED WHILE SETTING-UP TO THE PROCEDURE. IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE. NO DELAYS OCCURRED. 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 11617293 ↗
• MalfunctionMar 31, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD WAS BLACKED OUT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11598741 ↗
• MalfunctionMar 24, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING SURGERY, THE CAMERA HEAD HAD NO IMAGE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. 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 11560782 ↗
• MalfunctionMar 24, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING SURGERY, THE CAMERA HEAD HAD NO IMAGE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. 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 11560761 ↗
• MalfunctionMar 24, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING SURGERY, THE CAMERA HEAD HAD NO IMAGE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. 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 11560704 ↗
• MalfunctionMar 17, 2021No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION FOR A KNEE SCOPE, THE CAMERA HEAD LENS INT SYS COULD NOT FUNCTION WHEN PLUGGING IN THE LENS. THE DEVICE SHOWED COLOR BARS ON THE SCREEN, NO IMAGE WAS SHOWING. THE PROCEDURE WAS FINISHED WITH A BACK UP DEVICE WITH NO SIGNIFICANT DELAY. NO PATIENT INVOLVED AT THE MOMENT OF THE INCIDENT. 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 11509906 ↗
• MalfunctionMar 13, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE CAMERA HEAD WAS NOT TAKING PICTURES. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. UNKNOWN IF THERE WAS A DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478525 ↗