LENS 72204354SRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00885556632000), received between Oct 11, 2017 and Jul 18, 2021 — classified as 35 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (21 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2021No Display/Image; Electrical /Electronic Property Problem; No Display/Image; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE LENS INTEGRATED SYSTEM WILL NOT PRODUCE LIGHT FOR THE LIGHT CORD. INCIDENT OCCURRED WHILE SETTING-UP TO THE PROCEDURE. A BACK-UP DEVICE WAS AVAILABLE AND NO DELAYS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186636 ↗
• MalfunctionJun 3, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SERVICE REPL LENS LIGHT WAS NOT WORKING. NO PATIENT WAS INVOLVED AS THE FAILURE WAS FOUND BEFORE THE SURGERY. NO DELAY WAS REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11936030 ↗
• MalfunctionMay 29, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE LIGHT OF THE LENS INTEGRATED SYSTEM WAS NOT TURNING ON. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905722 ↗
• MalfunctionMay 18, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE IMAGE OF THE SERVICE REPL LENS SYSTEM IS YELLOWISH. NO CASE INVOLVED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT'S LAMP WAS NOT GIVING ANY LIGHT WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11840610 ↗
• MalfunctionMay 17, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE LIGHT SOURCE OF THE LENS STOPPED WORKING. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832355 ↗
• MalfunctionMay 13, 2021No Display/Image; Electrical /Electronic Property Problem; No Display/Image; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT, THE INDICATOR LED OF THE "LENS INTEGRATED SYSTEM - WIFI VERSION" DID NOT LIGHT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11823371 ↗
• MalfunctionMay 11, 2021No Display/Image; Electrical /Electronic Property Problem; No Display/Image; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT, THE LIGHT IN "LENS INTEGRATED SYSTEM WIFI VERSION" DIE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11808642 ↗
• MalfunctionApr 18, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE LED LIGHT OF THE LENS INTEGRATED SYSTEM WAS OBSTRUCTED. 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 11683400 ↗
• MalfunctionApr 6, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING THE SET UP BEFORE THE SURGERY THE LIGHT SOURCE WAS NOT TURNING ON. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE 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 11618447 ↗
• MalfunctionMar 22, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SERVICE REPL LENS INT SYS WIFI VER'S LIGHT SOURCE WAS NOT PRODUCING LIGHT. 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 11544190 ↗
• MalfunctionMar 7, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE LENS INTEGRATED SYSTEM WIFI VERSION HAD NO CONNECTION, THE ANTENNA WAS LOOSE. NO CASE WAS 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 11430059 ↗
• MalfunctionDec 1, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE THE LENS INTEGRATED SYSTEM KEPT GOING BLACK AND DROPPING WI-FI CONNECTION. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO DELAY OR PATIENT INJURY WAS REPORTED. 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 10930931 ↗
• MalfunctionDec 1, 2020Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT, DURING SURGERY, THE LENS UNIT WAS NOT EMITTING LIGHT WHEN CAMERA HEAD WAS INSERTED INTO PATIENT. THE PROCEDURE WAS COMPLETED WITH A ONE HOUR DELAY USING A BACK-UP DEVICE, THE PATIENT'S ANESTHESIA TIME WAS PROLONGED. NO PATIENT INJURY WAS REPORTED. 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 10928296 ↗
• MalfunctionNov 11, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT, BEFORE A KNEE ARTHROSCOPY, THE LENS INTEGRATED SYSTEM WENT BLACK. NO PATIENT INVOLVEMENT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10825418 ↗
• MalfunctionOct 22, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING SHOULDER SCOPE, THE ASCOPE LENS WAS DROPPING THE SIGNAL; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. 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 10718681 ↗
• MalfunctionOct 7, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SERVICE REPLLENS SOMETIMES DID NOT LIGHT UP. NO CASE WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10646501 ↗
• MalfunctionOct 1, 2020Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE LIGHT OF THE LENS INTEGRATED SYSTEM COULD NOT TURN ON. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY, AND IF THERE WAS A PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10611147 ↗
• MalfunctionSep 22, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A KNEE SCOPE PROCEDURE, THE SERVICE REPLLENS INT SYS WIFI VER HAD AN INTERFERENCE ISSUE, THE IMAGE DROPPING AND BLACK SCREEN. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. 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 10566707 ↗
• MalfunctionSep 21, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THE LENS INT SYS WIFI PRESENTED RF INTERFERENCE ISSUES. ALSO THE IMAGE DROPPED TO A BLACK SCREEN DURING CASE. IT IS UNKNOWN WHAT KIND OF PROCEDURE WAS BEING PERFORMED NO FURTHER INFORMATION IS AVAILABLE. 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 10564455 ↗
• MalfunctionSep 20, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING SURGERY, THE LENS INTEGRATED SYSTEM HAD A RF INTERFERENCE ISSUE, THE IMAGE DROPPING AND THE SCREEN WAS BLACK. 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 Known Impact Or Consequence To Patient

  MAUDE report 10557957 ↗
• MalfunctionSep 1, 2020No Display/Image; Electrical /Electronic Property Problem; No Display/Image; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE LENS HAD AN ELECTRICAL ISSUE AND THERE WAS NO VIDEO, IT HAD TO BE RESTARTED. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10477286 ↗
• MalfunctionAug 26, 2020Unintended Power Up; Power Problem; Unintended Power Up; Power Problem

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, THE SERVICE REPL LENS HAD A POWERING ISSUES. IT IS UNKNOWN IF A BACKUP DEVICE WAS AVAILABLE. HOWEVER, A DELAY GREATER THAN 30 MINUTES WAS REPORTED. 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 10454978 ↗
• MalfunctionAug 4, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE SCREEN WAS GOING BLACK, A BLACK LINE APPEARED IN THE MIDDLE OF THE MONITOR AND THEN THERE WAS NO IMAGE AT THE BEGINNING OF THE PROCEDURE. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. 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 10365643 ↗
• MalfunctionJul 30, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, THE "LENS INTEGRATED SYSTEM WI-FI VERSION" BLACKED OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES 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 10347275 ↗
• MalfunctionFeb 3, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING KNEE ARTHROSCOPY PROCEDURE, THE LENS WAS OVERHEATING. IT IS UNKNOWN WHETHER THERE WAS A BACK UP AVAILABLE OR DELAY IN THE CASE. 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 9663174 ↗