Alcon, Engauge 8065751593Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00380657515936), received between Mar 24, 2021 and Dec 2, 2025 — classified as 3 injuries, 25 malfunctions.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Defective Component; Defective Component

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING VITRECTOMY SURGERY AN OPHTHALMIC LASER PROBE WOULD NOT FIT THROUGH THE PORT. PROCEDURE DETAILS HAVE NOT BEEN PROVIDED AND THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692265 ↗
• MalfunctionOct 31, 2025Defective Component; Defective Component

  A PHYSICIAN REPORTED THAT, PRIOR TO CATARACT SURGERY, AN OPHTHALMIC LASER PROBE GOT CAUGHT AND COULD NOT BE ATTACHED DURING TESTING. THE SURGERY WAS COMPLETED THE SAME DAY USING ANOTHER PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435089 ↗
• MalfunctionJan 17, 2025Difficult to Insert; Difficult to Insert

  A CUSTOMER REPORTED THAT THE OPHTHALMIC LASER PROBE WAS DIFFICULT TO INSERT THROUGH A TROCAR CANNULA. THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY AN ALTERNATIVE LASER PROBE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21176834 ↗
• MalfunctionJun 27, 2024Contamination; Fitting Problem; Contamination; Fitting Problem

  A NURSE REPORTED THAT AN OPHTHALMIC LASER PROBE HAD HAIR WRAPPED AROUND IT AND CROWING ON PROBE PREVENTS IT FROM COMING BETWEEN TROCAR BEFORE VITREORETINAL SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH ANOTHER PROBE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19622723 ↗
• MalfunctionDec 12, 2023Fitting Problem; Fitting Problem

  A HEALTH PROFESSIONAL REPORTED THAT AN OPHTHALMIC PROBE'S TIP WAS VENDING AND DID NOT GO THROUGH THE TROCAR DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18308678 ↗
• MalfunctionNov 3, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT PRODUCT COULD NOT BE INSERTED INTO THE TROCAR DURING SURGERY. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064267 ↗
• MalfunctionSep 14, 2023Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT DURING VITRECTOMY AN OPHTHALMIC LASER PROBE DID NOT GO THROUGH TROCAR. SURGERY WAS COMPLETED USING ANOTHER PRODUCT AND PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743939 ↗
• MalfunctionAug 16, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT THE DURING THE CATARACT SURGERY, OPHTHALMIC TIP COULD NOT BE INSERTED INTO THE PORT DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE INVOLVED EYE AND THE PATIENT IDENTIFIER ARE NOT AVAILABLE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561698 ↗
• MalfunctionJul 12, 2023Fitting Problem; Appropriate Device Problem Term/Code Not Available; Fitting Problem; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC PROBE COULD NOT BE INSERTED AND NOT BE EMITTED. THE SURGERY WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313651 ↗
• MalfunctionJul 7, 2023Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER PROBE DID NOT FIT INTI THE TROCAR BEFORE THE VITRECTOMY SURGERY. AN ALTERNATE PROBE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278379 ↗
• MalfunctionJun 27, 2023Fitting Problem; Defective Component; Fitting Problem; Defective Component

  A PHYSICIAN REPORTED THAT DURING A SURGERY AN OPHTHALMIC LASER PROBE WAS STUCK IN TROCAR. SURGERY WAS COMPLETED AFTER REPLACING THE PAK WITH ANOTHER ONE. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED CLARIFYING THAT THE PROBE NEEDLE COULDN'T REACH TO RETINA AND IT WAS FELT SHORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17208716 ↗
• MalfunctionJun 2, 2023Fitting Problem; Fitting Problem

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050051 ↗
• MalfunctionApr 27, 2023Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT THEY COULD NOT INSERT A LASER PROBE BECAUSE THE CONNECTOR SHAPE OF THE PROBE WAS DIFFERENT FROM THE CONSOLE. THERE WAS NO REPORT OF ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16822581 ↗
• InjuryApr 14, 2023Energy Output Problem; Energy Output Problem

  A PHYSICIAN REPORTED THAT DURING A VITRECTOMY WHILE USING AN OPHTHALMIC LASER PROBE FOR CORRECTING THE RETINAL DETACHMENT THE PROBE HAS NOT CAUSED RETINAL WHITENING. SINCE THE PROBE HAS NOT WORKED EFFECTIVELY POWER WAS ADJUSTED TO ADDRESS THE ISSUE (FROM 160MW UP TO240NM). HOWEVER, THIS WAS UNSUCCESSFUL. THE PROBE WAS SWITCHED WITH ANOTHER OF ITS KIND, AND THE SAME THING OCCURRED. THE PROCEDURE WAS CHANGED AND REQUIRED A CHANGE IN THE TECHNIQUE WITH CRYOPEXY WITH GAS PROBE (LASER VS CRYOPEXY) AND THE PATIENT CONDITION IS NORMAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16743393 ↗
• InjuryApr 14, 2023Energy Output Problem; Energy Output Problem

  A PHYSICIAN REPORTED THAT DURING A VITRECTOMY WHILE USING AN OPHTHALMIC LASER PROBE FOR CORRECTING THE RETINAL DETACHMENT THE PROBE HAS NOT CAUSED RETINAL WHITENING. SINCE THE PROBE HAS NOT WORKED EFFECTIVELY POWER WAS ADJUSTED TO ADDRESS THE ISSUE (FROM 160MW UP TO240NM). HOWEVER, THIS WAS UNSUCCESSFUL. THE PROBE WAS SWITCHED WITH ANOTHER OF ITS KIND, AND THE SAME THING OCCURRED. THE PROCEDURE WAS CHANGED AND REQUIRED A CHANGE IN THE TECHNIQUE WITH CRYOPEXY WITH GAS PROBE (LASER VS CRYOPEXY) AND THE PATIENT CONDITION IS NORMAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16743391 ↗
• MalfunctionFeb 28, 2023Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT DURING A VITRECTOMY, RETINAL DETACHMENT SURGERY AN OPHTHALMIC LASER PROBE DIDN'T PASS THROUGH THE TROCAR. THE SURGERY WAS COMPLETED AFTER CHANGING THE PRODUCT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451607 ↗
• MalfunctionJan 18, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING A VITRECTOMY AN OPHTHALMIC LASER PROBE TIP WAS CAUGHT IN THE PORT. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THERE'S NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16192107 ↗
• MalfunctionJan 16, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING A VITRECTOMY WHILE USING AN OPHTHALMIC LASER PROBE, TIP OF THE PROBE GOT CAUGHT IN OPHTHALMIC TROCAR PORT. SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16172830 ↗
• MalfunctionDec 19, 2022Difficult to Insert; Difficult to Insert

  A PHYSICIAN REPORTED THAT DURING A VITRECTOMY SURGERY AN OPHTHALMIC FLEXIBLE TIPS OF THE LASER PROBE (TWO) COULD NOT BE INSERTED TO CANNULA. THE PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16003651 ↗
• MalfunctionOct 21, 2022Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT DURING VITRECTOMY SURGERY OPHTHALMIC LASER PROBE WAS NOT FIT SMOOTHLY INTO THE INLET IT WAS SUPPOSED TO GO INTO. THE PROCEDURE WAS COMPLETED AFTER REPLACING WITH ANOTHER PROBE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15645783 ↗
• MalfunctionAug 29, 2022Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT A OPHTHALMIC LASER PROBE GOT CAUGHT IN A PORT AND COULD NOT BE INSERTED INTO THE PATIENT'S EYE DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE'S NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15312116 ↗
• MalfunctionAug 26, 2022Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT A LASER PROBE DID NOT FIX ON THE TROCAR DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15300209 ↗
• MalfunctionDec 1, 2021Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT AN OPHTHALMIC LASER PROBE DID NOT FIT THROUGH TROCAR CANNULA DURING SETUP OF A VITRECTOMY PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909762 ↗
• MalfunctionNov 18, 2021Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT BEFORE A CATARACT SURGERY, AN OPHTHALMIC LASER PROBE DID NOT FIT THROUGH CANNULA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12838072 ↗
• InjuryOct 7, 2021Failure to Fire; Failure to Fire

  A PHYSICIAN REPORTED THAT DURING A SURGICAL PROCEDURE TO REPAIR A RETINAL DETACHMENT ON THE PATIENTS RIGHT EYE THE LASER PROBE EMISSION FAILED. DUE TO THE EMISSION FAILURE THE PATIENT EXPERIENCED A HOLE IN THE RETINA. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE LASER PROBE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE EVENT OCCURRED DURING A VITRECTOMY PROCEDURE. AFTER AIR SUBSTITUTION WAS PERFORMED THE RETINA WHERE THE LASER SPOT WAS PERFORMED TORE AND BLEED. THE PATIENT WILL BE MONITORED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Retinal Tear

  MAUDE report 12593289 ↗