LENSRecalls & reported problems across all models
Smith & Nephew, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 450
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 0
We found 8 models of LENS by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 450 adverse event reports in the FDA's MAUDE database, received between Aug 17, 2017 and Jun 8, 2026 — classified as 15 injuries, 435 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (218 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported LENS problems
Device problems
- No Display/Image218
- Overheating of Device55
- Display or Visual Feedback Problem25
- Optical Problem17
- Insufficient Device Problem Information16
- Failure to Power Up12
- Poor Quality Image12
- Unexpected Shutdown12
Patient problems
- No Clinical Signs, Symptoms or Conditions197
- No Known Impact Or Consequence To Patient186
- No Patient Involvement48
- No Information13
- No Consequences Or Impact To Patient8
- Injury1
- Insufficient Information1
LENS models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LENS 72203967Arthroscope175 reports
- LENS 72204354Laparoscope, General & Plastic Surgery126 reports
- LENS 72203967SLaparoscope, general & plastic surgery94 reports
- LENS 72204354SLaparoscope, general & plastic surgery35 reports
- LENS 72204725Laparoscope, general & plastic surgery10 reports
- LENS 72204685Laparoscope, general & plastic surgery8 reports
- LENS 72204685SLaparoscope, general & plastic surgery1 report
- LENS 72204725SLaparoscope, general & plastic surgery1 report
Recent LENS adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 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 ↗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 ↗MalfunctionJul 2, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE COUPLER FOCUS RING WAS JAMMED. THE PROCEDURE WAS COMPLETED USING THE SAME REPORTED DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22391676 ↗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 ↗MalfunctionJun 11, 2025Optical Discoloration; Optical Discoloration
IT WAS REPORTED THAT DURING SET UP OF THE EQUIPMENT, THE CAMERA COUPLER WAS CONNECTED AND SHOWED A GREEN VIEW. THEY TRIED TO CONNECT AND TEST IT ONCE MORE, OBTAINING THE SAME RESULT. THE PROCEDURE WAS CANCELED AS THERE WAS NO BACKUP DEVICE. THE PATIENT IS STABLE AS THE PROCEDURE WAS RESCHEDULED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22181696 ↗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 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 ↗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 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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