LENS 72204685Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556617908), received between Aug 9, 2018 and Jun 2, 2021 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING USE IN AN ARTHROSCOPIC KNEE SURGERY, ON THE LENS INTEGRATED SYSTEM APPEARS AS A YELLOW SORT OF HAZE ON SCREEN, PRODUCING A SCREEN IMAGE NOT RECOGNIZABLE AND NOT ALLOWING THE SURGERY TO CONTINUE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11924359 ↗
• MalfunctionAug 21, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A SURGERY THE LENS INTEGRATED SYSTEM NON-WIFI VERSION PICTURE DISAPPEARED. THE DEVICE WAS REBOOTED AND IT WORKED FINE. THERE WAS A SOFTWARE INCOMPATIBILITY BETWEEN THE LENS INTEGRATED SYSTEM AND THE CAMERA HEAD. IT IS UNKNOWN IF THERE WAS AN AVAILABLE BACK UP DEVICE OR A SIGNIFICANT DELAY DURING THE PROCEDURE. NO PATIENT INJURY OR OTHER COMPLICATIONS 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 10437983 ↗
• MalfunctionAug 21, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A SURGERY THE LENS CAMERA HEAD PICTURE DISAPPEARED. THE DEVICE WAS REBOOTED AND IT WORKED FINE. THERE WAS A SOFTWARE INCOMPATIBILITY BETWEEN THE LENS INTEGRATED SYSTEM AND THE CAMERA HEAD. IT IS UNKNOWN IF THERE WAS AN AVAILABLE BACK UP DEVICE OR A SIGNIFICANT DELAY DURING THE PROCEDURE. NO PATIENT INJURY OR OTHER COMPLICATIONS 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 10437955 ↗
• MalfunctionAug 19, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A SURGERY THE LENS CAMERA HEAD PICTURE DISAPPEARED. OR STAFF SUSPECTS WAS A SOFTWARE INCOMPATIBILITY BETWEEN THE LENS INTEGRATED SYSTEM AND THE CAMERA HEAD. IT IS UNKNOWN IF THERE WAS AN AVAILABLE BACK UP DEVICE OR A SIGNIFICANT DELAY DURING THE PROCEDURE. NO PATIENT INJURY OR OTHER COMPLICATIONS 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 10428989 ↗
• MalfunctionSep 4, 2018Poor Quality Image

  IT WAS REPORTED THAT SINCE LENS SYSTEM INSTALLED, YELLOW TINTED IMAGE SHOW UP OCCASIONALLY. REPLACED CCU 4 TIMES (4 CCUS FAILED) AND CAMERA HEAD, LIGHT CABLE, SCOPES ALL HAVE BEEN CHANGED AND CHECK CONDITION IS FULLY GOOD. HOWEVER STILL YELLOW IMAGE SHOWS UP. NO PATIENT INJURY WAS REPORTED. BACK UP WAS USED TO COMPLETE THE PROCEDURE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7844097 ↗
• MalfunctionSep 4, 2018Display or Visual Feedback Problem

  IT WAS REPORTED THAT SINCE LENS SYSTEM INSTALLED, YELLOW TINTED IMAGE SHOW UP OCCASIONALLY. REPLACED CCU 4 TIMES (4 CCUS FAILED) AND CAMERA HEAD, LIGHT CABLE, SCOPES ALL HAVE BEEN CHANGED AND CHECK CONDITION IS FULLY GOOD. HOWEVER STILL YELLOW IMAGE SHOWS UP. NO PATIENT INJURY WAS REPORTED. BACK UP WAS USED TO COMPLETE THE PROCEDURE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7844038 ↗
• MalfunctionSep 4, 2018Display or Visual Feedback Problem

  IT WAS REPORTED THAT SINCE LENS SYSTEM INSTALLED, YELLOW TINTED IMAGE SHOW UP OCCASIONALLY. REPLACED CCU 4 TIMES (4 CCUS FAILED) AND CAMERA HEAD, LIGHT CABLE, SCOPES ALL HAVE BEEN CHANGED AND CHECK CONDITION IS FULLY GOOD. HOWEVER STILL YELLOW IMAGE SHOWS UP. NO PATIENT INJURY WAS REPORTED. BACK UP WAS USED TO COMPLETE THE PROCEDURE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7843957 ↗
• MalfunctionAug 9, 2018Image Display Error/Artifact

  IT WAS REPORTED THAT SINCE LENS SYSTEM INSTALLED, YELLOW TINTED IMAGE SHOW UP OCCASIONALLY. THE DEVICE WAS TEST WITH DIFFERENT DEVICES AND THE ISSUE PERSISTS. A SIGNIFICANT DELAY WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7768914 ↗