LENS 72204354Recalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 00885556617878), received between Aug 17, 2017 and Jun 8, 2026 — classified as 7 injuries, 119 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (47 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 25 most recent of 126 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Optical Problem

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, ONE (1) LENS INTEGRATED SYSTEM WIFI VERSION WAS NOT EMITTING THE PROPER LIGHT. THE PROCEDURE RESUMED, A DELAY GREATER THAN 30 MIN AFTER A SIGNIFICANT DELAY OF MORE THAN 30 MINUTES, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25426214 ↗
• MalfunctionDec 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ACL SURGERY, THE LIGHT SOURCE TURRET OF ONE (1) LENS INTEGRATED SYSTEM WAS NOT WORKING. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MIN, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705200 ↗
• MalfunctionSep 16, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT, DURING SURGERY, THE LENS INTEGRATED SYSTEM HAD A LIGHT INTENSITY ISSUE. SURGERY WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23068986 ↗
• MalfunctionAug 26, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT THE DURING AN ACL PROCEDURE, LIGHT INTENSITY OF THE LENS INTEGRATED SYSTEM HAD AN ISSUE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE AND THERE WAS A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901017 ↗
• MalfunctionAug 12, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE LENS INTEGRATED SYSTEM'S LIGHT SOURCE WAS INTERMITTENTLY SWITCHING OFF. SURGERY WAS COMPLETED WITH THE SAME REPORTED 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 22783456 ↗
• MalfunctionMay 15, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE LIGHT SOURCE OF THE LENS INTEGRATED SYSTEM WAS NOT EMITTING PROPER LIGHT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023869 ↗
• MalfunctionJan 16, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE LIGHT SOURCE OF THE LENS INTEGRATED SYSTEM WAS EMITTING A YELLOW LIGHT AND WAS HAMPERING THE VISION. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR 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 21171821 ↗
• MalfunctionJan 6, 2025No Device Output; Optical Problem; No Device Output; Optical Problem

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY THE LIGHT SOURCE OF THE LENS INTEGRATED SYSTEM WAS NOT FUNCTIONING. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. 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 21079373 ↗
• MalfunctionDec 6, 2024Power Problem; Power Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE LIGHT SOURCE OF THE LENS INTEGRATED SYSTEM WAS NOT EMITTING LIGHT THOUGH TRIED WITH DIFFERENT LIGHT CABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20861145 ↗
• MalfunctionNov 18, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE LENS INTEGRATED SYSTEM'S LIGHT SOURCE WAS EMITTING A YELLOW LIGHT AFFECTING THE VISION AND IMAGE. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN COMPETITOR DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20705544 ↗
• MalfunctionOct 2, 2024Display or Visual Feedback Problem; Poor Visibility; Display or Visual Feedback Problem; Poor Visibility

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE CAMERA DID NOT ALLOW ADEQUATE VISUALIZATION OF THE SURGICAL FIELD, THE IMAGE WAS RAINY AND DID NOT ALLOW AN OPTIMAL VISUAL FIELD. THE PROCEDURE WAS COMPLETED THE SAME FAULTY DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AS EXTENDED ANESTHESIA TIME BEYOND WAS REQUIRED, AND IT WAS A COMPLEX PROCEDURE TO COMPLETE DUE TO LOW VISIBILITY, NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20356536 ↗
• MalfunctionOct 2, 2024Display or Visual Feedback Problem; Poor Visibility; Display or Visual Feedback Problem; Poor Visibility

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE CAMERA DID NOT ALLOW ADEQUATE VISUALIZATION OF THE SURGICAL FIELD, THE IMAGE WAS RAINY AND DID NOT ALLOW AN OPTIMAL VISUAL FIELD. THE PROCEDURE WAS COMPLETED THE SAME FAULTY DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AS EXTENDED ANESTHESIA TIME BEYOND WAS REQUIRED, AND IT WAS A COMPLEX PROCEDURE TO COMPLETE DUE TO LOW VISIBILITY, NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20356452 ↗
• MalfunctionOct 2, 2024Display or Visual Feedback Problem; Poor Visibility; Display or Visual Feedback Problem; Poor Visibility

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE CAMERA DID NOT ALLOW ADEQUATE VISUALIZATION OF THE SURGICAL FIELD, THE IMAGE WAS RAINY AND DID NOT ALLOW AN OPTIMAL VISUAL FIELD. THE PROCEDURE WAS COMPLETED THE SAME FAULTY DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AS EXTENDED ANESTHESIA TIME BEYOND WAS REQUIRED, AND IT WAS A COMPLEX PROCEDURE TO COMPLETE DUE TO LOW VISIBILITY, NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20356448 ↗
• MalfunctionOct 2, 2024Display or Visual Feedback Problem; Poor Visibility; Display or Visual Feedback Problem; Poor Visibility

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE CAMERA DID NOT ALLOW ADEQUATE VISUALIZATION OF THE SURGICAL FIELD, THE IMAGE WAS RAINY AND DID NOT ALLOW AN OPTIMAL VISUAL FIELD. THE PROCEDURE WAS COMPLETED THE SAME FAULTY DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AS EXTENDED ANESTHESIA TIME BEYOND WAS REQUIRED, AND IT WAS A COMPLEX PROCEDURE TO COMPLETE DUE TO LOW VISIBILITY, NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20356446 ↗
• MalfunctionSep 30, 2024Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE LENS INTEGRATED SYSTEM LIGHT WAS TOO LOW. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES, AND USING THE SAME FAULTY DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20340522 ↗
• MalfunctionAug 27, 2024Optical Problem; Optical Problem

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE LENS INTEGRATED SYSTEM HAD NO LIGHT OUTPUT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF MORE THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081844 ↗
• MalfunctionJun 28, 2024Calibration Problem; Connection Problem; Optical Discoloration; Calibration Problem; Connection Problem; Optical Discoloration

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE LENS INTEGRATED SYSTEM, AND IT WAS NOT MAKING THE WHITE BALANCE, BESIDE THE IMAGE WAS VERY YELLOW. THE DOCTOR HAD TO USE THE HOUSE'S VIDEO CABINET. THE PROCEDURE WAS COMPLETED USING THE SAME REPORTED DEVICE. THERE WAS 45 MINUTE DELAY NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19638790 ↗
• MalfunctionDec 8, 2023Optical Problem; Optical Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE LIGHT SOURCE OF THE LENS INTEGRATED SYSTEM WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18293502 ↗
• MalfunctionDec 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE LENS INTEGRATED SYSTEM WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287983 ↗
• MalfunctionNov 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE LIGHT SOURCE OF THE LENS INTEGRATED SYSTEM WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE WITH A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18204573 ↗
• MalfunctionMay 2, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ACL, A LENS INTEGRATED SYSTEM HAD ITS KENS ROD AND LIGHT SOURCE DAMAGED. SURGERY RESUMED AFTER A DELAY GREATER THAN 30 MINUTES WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16855181 ↗
• MalfunctionFeb 9, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE LIGHT SOURCE OF THE LENS INTEGRATED SYSTEM WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16334951 ↗
• MalfunctionNov 17, 2022Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHILE THE PATIENT WAS ANESTHETIZED, THE LENS SURGICAL IMAGING SYSTEM COULD NOT PROVIDE OUTPUT IMAGE AS DESIRED. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15811772 ↗
• MalfunctionOct 4, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE LIGHT SOURCE OF THE LENS INTEGRATED SYSTEM WAS NOT WORKING. SURGERY WAS RESUMED AFTER A DELAY GREATER THAN 30 MINUTES, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536642 ↗
• MalfunctionMay 25, 2022Optical Discoloration; Optical Discoloration

  IT WAS REPORTED THAT DURING USE, THE COLOR IMAGE OF THE LENS INTEGRATED SYSTEM WAS WOBBLING, THERE WAS COMPLETE COLOR CHANGE IN THE MONITOR. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14497769 ↗