Alcon, Engauge 8065751113Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00380657511136), received between May 31, 2021 and Sep 18, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (16 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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Defective Component; Defective Component

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC PROBE DID NOT ENTER THE TROCAR. THE SURGERY COMPLETED ON THE SAME DAY WITHOUT PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23082673 ↗
• MalfunctionJun 27, 2025Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT DURING A PHOTOCOAGULATION SURGERY, THE TIP OF THE LASER PROBE COULD NOT BE INSERTED INTO THE PUNCTURE PORT OF THE SAME SPECIFICATION APERTURE. THE SURGERY WAS COMPLETED ON THE SAME DAY USING AN ALTERNATIVE PROBE, AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344035 ↗
• MalfunctionAug 28, 2024Energy Output Problem; Energy Output Problem

  A GOVERNMENT AGENCY REPORTED THAT DURING VITRECTOMY AND INTRAOCULAR PHOTOCOAGULATION SURGERY ON THE LEFT EYE, AN OPHTHALMIC LASER PROBE DID NOT RESPOND, NO LASER SPOT, AND NO RED AIMING BEAM. SURGERY WAS COMPLETED ON THE SAME DAY WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20084774 ↗
• MalfunctionMay 30, 2024Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT AN OPHTHALMIC PROBE WOULD NOT FIT THROUGH THE TROCAR DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT HARM. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19422706 ↗
• MalfunctionApr 19, 2024Defective Component; Defective Component

  A NURSE REPORTED THAT DURING VITRECTOMY SURGERY, THE TIP OF LASER PROBE WAS TOO THICK TO ENTER THE CANNULA PROPERLY. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142202 ↗
• MalfunctionApr 11, 2024Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC PROBE WAS NOT ENTERING TROCAR CANNULA DURING SURGERY. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT HAPPENED DURING RETINAL DETACHMENT. THE SURGERY WAS COMPLETED WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087408 ↗
• MalfunctionFeb 7, 2024Fitting Problem; Fitting Problem

  A GOVERNMENT AGENCY REPORTED THAT AN OPHTHALMIC LASER HEAD COULD NOT ENTER THE CORRESPONDING SCLERAL NAIL. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18658419 ↗
• MalfunctionDec 12, 2023Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT AN OPHTHALMIC OPERATING PROBE WAS THINK AND IT COULD NOT BE INSERTED INTO THE CANNULA DURING THE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT AND THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18309029 ↗
• MalfunctionOct 30, 2023Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT DURING THE VITRECTOMY PROCEDURE, OPHTHALMIC LASER FIBER WAS TOO THICK TO FIT INTO THE CANNULA. PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18029936 ↗
• MalfunctionSep 19, 2023Fitting Problem; Fitting Problem

  HOLD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774046 ↗
• MalfunctionAug 31, 2023Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT BEFORE VITRECTOMY SURGERY AN OPHTHALMIC OPERATING PROBE COULD NOT PUT IN CANNULA. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17661807 ↗
• MalfunctionJun 1, 2023Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT AN OPHTHALMIC LASER PROBE COULD NOT PASS THROUGH TROCAR. THE SURGERY WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17036208 ↗
• MalfunctionApr 14, 2023Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT BEFORE A VITRECTOMY PROCEDURE AN OPHTHALMIC LASER PROBE HEAD WAS UNEVEN AND CANNOT FIT INTO THE EYE. THE SURGERY WAS COMPLETED USING NEW PRODUCT AND PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742459 ↗
• MalfunctionMar 16, 2023Fitting Problem; Fitting Problem

  THE PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY AN OPHTHALMIC PROBE WOULD NOT PASS THROUGH THE CANNULA. THE SURGERY WAS COMPLETED WITH ANOTHER PRODUCT. THERE IS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16551971 ↗
• MalfunctionFeb 22, 2023Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT DURING A VITRECTOMY PROCEDURE, A FLEXIBLE OPHTHALMIC LASER FIBER WAS INTRODUCED INTO THE TROCAR AND IT DID NOT PASS THROUGH IT, APPARENTLY IT CONTAINED A DIAMETER GREATER THAN THE REQUIRED CALIBER. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH A NEW FIBER. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416097 ↗
• MalfunctionDec 9, 2022Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC LASER PROBE WAS FOUND TO BE DEFECTIVE AND COULD NOT GO THROUGH THE TROCAR AS WELL DURING A SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY BY REPLACING THE LASER PROBE WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950151 ↗
• MalfunctionJul 6, 2022Fitting Problem; Fitting Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COMBINATION OF A CATARACT AND VITRECTOMY SURGERY AN OPHTHALMIC LASER PROBE WOULD NOT GO COMPLETELY INTO THE TROCAR. PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14939323 ↗
• MalfunctionJun 20, 2022Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT DURING A COMBINATION OF CATARACT AND VITRECTOMY SURGERY SURGEON FELT RESISTANCE WHILE INSERTING TIP INTO CANNULA. THE PROBE WAS STUCK HALFWAY AND COULD NOT BE FULLY INSERTED INTO THE CANNULA. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14746849 ↗
• MalfunctionMay 31, 2021Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT DURING SURGERY THE LASER PROBE WOULD NOT GO THROUGH TROCAR. THERE WAS A PATIENT CONTACT BUT THERE WAS NO PATIENT IMPACT NOTED. THE PROCEDURE WAS COMPLETED BY USING NEW LASER PROBE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED AS RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11907230 ↗