LENS 72203967Recalls & reported problems
Smith & Nephew, Inc. · CAMERA HEAD LENS INTEGRATED SYSTEM · Class 2
All models of LENS (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Smith & Nephew LENS camera head for arthroscopy has 175 adverse event reports, with no deaths and 7 injuries. The reports mostly describe no display or image, overheating, and buttons that stop working, and some surgeries were delayed. No recalls name this device, and reports fell to 1 in the latest 12 months from 12 in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 175
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 175 adverse event reports that list this exact device (DI 00885556629833), received between Nov 22, 2017 and Apr 5, 2026 — classified as 7 injuries, 168 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (86 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.
Reports received per month
Most reported problems
Device problems
- No Display/Image86
- Overheating of Device41
- Display or Visual Feedback Problem8
- Insufficient Device Problem Information7
- Connection Problem6
- Poor Quality Image6
- Optical Problem5
- Key or Button Unresponsive/not Working4
Patient problems
- No Clinical Signs, Symptoms or Conditions81
- No Known Impact Or Consequence To Patient64
- No Patient Involvement22
- No Consequences Or Impact To Patient4
- No Information4
- Injury1
Recent adverse event reports
The 25 most recent of 175 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 5, 2026Key or Button Unresponsive/not Working
IT WAS REPORTED THAT, DURING AN ACL SURGERY, THE LEFT AND CENTER BUTTONS OF ONE (1) CAMERA HEAD WERE NOT FUNCTIONING. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING THE SAME DEVICE. 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 24787084 ↗MalfunctionJul 22, 2025Optical Distortion; Optical Distortion
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, ONE (1) LENS CAMERA HEAD HAD A DISTORTED IMAGE. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22562677 ↗MalfunctionJun 30, 2025Display or Visual Feedback Problem; Optical Distortion; Display or Visual Feedback Problem; Optical Distortion
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, ONE (1) LENS CAMERA HEAD HAD A BLURRY IMAGE, AND COMPROMISE IMAGE QUALITY DUE TO LOT OF NOISE. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22354482 ↗MalfunctionMay 15, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BUTTONS OF THE CAMERA HEAD WERE NOT WORKING AND WERE UNABLE TO TAKE PICTURES, RECORD VIDEO, OR CONTROL THE SYSTEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22024075 ↗MalfunctionMay 15, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BUTTONS OF THE CAMERA HEAD WERE NOT WORKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22024056 ↗MalfunctionMay 14, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CAMERA HEAD CABLE HAD A CONNECTION ISSUE. THE PROCEDURE WAS COMPLETED USING 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 22021461 ↗MalfunctionApr 27, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT, DURING SET-UP, THE CAMERA HEAD WAS HEATING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21916015 ↗MalfunctionJan 17, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING ROUTINE INSPECTION, IT WAS OBSERVED OVERHEAT IN THE CAMERA HEAD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21183523 ↗MalfunctionNov 26, 2024Optical Obstruction; Optical Obstruction
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE INTERNAL LENS OF THE CAMERA HEAD WAS GETTING COMPLETELY FOGGED AND THE VISION WAS HAMPERED ENTIRELY. 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 20785280 ↗MalfunctionNov 12, 2024Optical Obstruction; Optical Obstruction
IT WAS REPORTED THAT DURING A PROCEDURE, THE CAMERA HEAD HAD A FOGGING ISSUE. THE PROCEDURE WAS COMPLETED USING 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 20670006 ↗InjuryNov 6, 2024Overheating of Device; Insufficient Device Problem Information; Unexpected Shutdown; Overheating of Device; Insufficient Device Problem Information; Unexpected Shutdown
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE LIGHT OF THE CAMERA HEAD WOULD CUT OUT IN THE MIDDLE AND THE CAMERA CONNECTIONS HEATED UP AS SOON AS IT WAS PLUGGED IN. THE SURGEON HAD TO OPEN THE SHOULDER TO COMPLETE THE OPERATION CAUSING A MUCH LARGER INCISION. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS UNSPECIFIED DELAY REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20616362 ↗InjuryNov 5, 2024Overheating of Device; Insufficient Device Problem Information; Unexpected Shutdown; Overheating of Device; Insufficient Device Problem Information; Unexpected Shutdown
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE LIGHT OF THE CAMERA HEAD WOULD CUT OUT IN THE MIDDLE AND THE CAMERA CONNECTIONS HEATED UP AS SOON AS IT WAS PLUGGED IN. THE SURGEON HAD TO OPEN THE SHOULDER TO COMPLETE THE OPERATION CAUSING A MUCH LARGER INCISION. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS UNSPECIFIED DELAY REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20614820 ↗InjuryNov 5, 2024Overheating of Device; Insufficient Device Problem Information; Unexpected Shutdown; Overheating of Device; Insufficient Device Problem Information; Unexpected Shutdown
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE CAMERA HEAD HAD A VIDEO PROBLEM AND STOPPED WORKING. THE SURGEON HAD TO OPEN THE SHOULDER TO COMPLETE THE OPERATION CAUSING A MUCH LARGER INCISION. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS UNSPECIFIED DELAY REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20614274 ↗MalfunctionSep 2, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BUTTONS OF THE CAMERA HEAD WERE NOT WORKING. 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 20120473 ↗MalfunctionJun 28, 2024Overheating of Device; Calibration Problem; Connection Problem; Optical Discoloration; Device Contaminated at the User Facility; Overheating of Device; Calibration Problem; Connection Problem; Optical Discoloration; Device Contaminated at the User Facility
IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE CAMERA HEAD WAS HOT, THE CONTACT WAS DISCONNECTING FROM 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 19638753 ↗MalfunctionJun 19, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CAMERA HEAD WAS GETTING VERY HOT. T. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19570985 ↗MalfunctionApr 10, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CAMERA HEAD WAS OVERHEATING. · THE PROCEDURE WAS COMPLETED USING A 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 19081952 ↗MalfunctionMar 28, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, INSTRUMENTS OUTSIDE THE PATIENT, THE LENS CAMERA HEAD WAS GETTING VERY HOT AND FAILED. THERE WAS NO PATIENT HARM REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING THE SAME FAULTY DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18992061 ↗MalfunctionAug 7, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING SET UP, THE LENS CAMERA HEAD WARMED OUT. NO DELAY WAS REPORTED AND THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17471110 ↗MalfunctionAug 7, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING SET UP, THE LENS CAMERA HEAD WARMED OUT. NO DELAY WAS REPORTED AND THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17471090 ↗MalfunctionOct 4, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE CAMERA HEAD WAS GETTING MORE HEATED THAN NORMAL TEMPERATURE. 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 15536687 ↗MalfunctionJul 29, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE CAMERA HEAD WAS VERY HOT TO TOUCH. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED AND IF THERE WAS A SURGICAL DELAY DUE TO THE REPORTED EVENT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15135004 ↗MalfunctionJul 5, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING SET UP FOR AN ACL RECONSTRUCTION, THE CAMERA HEAD GAVE AN ERROR. THERE WAS A DISPLAY OF HORIZONTAL LINES ON THE MONITOR WHEN THE CAMERA HEAD CABLE WAS PLUGGED INTO THE PORT. THE NURSES DID THE INSPECTION 1 HOUR BEFORE THE SURGERY TIME. A S+N BACK-UP DEVICE WAS AVAILABLE. THERE WAS A SIGNIFICANT DELAY GREATER THAN 30MIN, AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14921038 ↗MalfunctionMay 25, 2022Optical Discoloration; Optical Discoloration
IT WAS REPORTED THAT DURING USE, THE COLOR IMAGE OF THE CAMERA HEAD 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 14497771 ↗MalfunctionFeb 28, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING SET UP OR INSPECTION, THE CAMERA HEAD WAS GETTING HOT. THERE WAS A S+N BACK-UP DEVICE AVAILABLE. NON-SIGNIFICANT DELAY WAS REPORTED, AND NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13626423 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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