Alcon, Engauge 8065751114Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00380657511143), received between Feb 11, 2020 and Nov 6, 2025 — classified as 1 injury, 73 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (63 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2025Fitting Problem; Defective Component; Fitting Problem; Defective Component

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC LASER PROBE WAS RESISTANCE AND WAS DIFFICULT TO INSERT INTO THE CONSOLE DURING SETUP. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. PROCEDURE DETAILS AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 23485706 ↗
• MalfunctionOct 30, 2025Defective Component; Defective Component

  A CUSTOMER REPORTED THAT DURING SET UP, AN OPHTHALMIC LASER PROBE WOULD NOT FIT IN THE PORT. THE SURGERY WAS COMPLETED BY USING NEW PROBE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423768 ↗
• MalfunctionOct 28, 2025Defective Component; Defective Component

  A CUSTOMER REPORTED THAT DURING VITREORETINAL SURGERY SHAFT OF AN OPHTHALMIC LASER PROBE HAD BULGE AND THAT WOULD NOT LET IT ENTER THROUGH THE PORT ON THE EYE. A NEW LASER PROBE WAS OPENED, AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402391 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Firing Problem; Adverse Event Without Identified Device or Use Problem; Firing Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE OPHTHALMIC LASER PROBE HAD BEEN TOO POWERFUL.

  Patient problems: Retinal Tear

  MAUDE report 22628656 ↗
• MalfunctionJun 16, 2025Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT DURING A RETINAL DETACHMENT REPAIR PROCEDURE ON THE RIGHT EYE, TWO OPHTHALMIC LASER PROBES FROM THE SAME BATCH BECAME STUCK IN THE TROCAR CANNULA, PREVENTING SMOOTH TRANSITION THROUGH THE PORT. WHEN THE PROBE WAS PULLED BACK, THE TROCAR WAS PULLED OUT ALONG WITH IT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE PROBE WITH ANOTHER ONE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22209894 ↗
• MalfunctionMay 2, 2025Defective Component; Defective Component

  A NURSE REPORTED THAT AN OPHTHALMIC LASER PROBE COULD NOT ENTER CANNULA DURING VITRECTOMY SURGERY. SURGERY WAS COMPLETED AFTER CHANGING PRODUCT WITH A NEW ONE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950516 ↗
• MalfunctionApr 24, 2025Fitting Problem; Fitting Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SETTING UP FOR VITRECTOMY SURGERY AN OPHTHALMIC LASER PROBE WAS UNABLE TO ENTER TROCAR. PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21897688 ↗
• MalfunctionApr 4, 2025Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT DURING VITRECTOMY, MEMBRANE PEEL, FLUID GAS EXCHANGE, SF6 GAS, MACULAR OLD REPAIR IN THE LEFT EYE OF THE PATIENT AN OPHTHALMIC LASER PROBE WOULD NOT FIT THROUGH CANNULA. THE SURGERY WAS COMPLETED IN THE SAME DAY AFTER REPLACING WITH ANOTHER PROBE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773824 ↗
• MalfunctionNov 27, 2024Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT, BEFORE THE POSTERIOR VITRECTOMY PROCEDURE, AN OPHTHALMIC LASER PROBE DID NOT ENTER THROUGH THE TROCAR. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH NO HARM TO THE PATIENT, AND THE PATIENT RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797423 ↗
• MalfunctionNov 5, 2024Difficult to Insert; Difficult to Insert

  A NURSE REPORTED THAT DURING VITRECTOMY PROCEDURE, TIP OF AN OPHTHALMIC LASER PROBE WAS ENTER INTO THE PATIENT'S EYE SMOOTHLY. SURGERY WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE PROBE AND WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612443 ↗
• MalfunctionSep 13, 2024Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT DURING CALIBRATION, AN OPHTHALMIC LASER PROBE DEFORMED AND COULD NOT PUT INTO THE TUBE FOR USAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20213125 ↗
• MalfunctionSep 4, 2024Energy Output Problem; Energy Output Problem

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY PROCEDURE, LASER FIRING WAS DIM. EVEN AFTER ADJUSTING THE ENERGY, AN OPHTHALMIC LASER PROBE STILL COULD NOT PRODUCE LASER SPOTS IN THE PATIENT'S FUNDUS. IN ADDITION, BUBBLES WERE GENERATED AT THE TIP OF LASER PROBE WHEN FIRING LASER. SURGERY WAS COMPLETED ON THE SAME DAY AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20133608 ↗
• MalfunctionAug 30, 2024Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT OPHTHALMIC LASER PROBE COULD NOT PORT INTO 25G TROCAR. PATIENT AND PROCEDURE DETAILS WERE NOT REPORTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20106263 ↗
• MalfunctionAug 30, 2024Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT BEFORE VITRECTOMY SURGERY, AN OPHTHALMIC LASER PROBE WAS NOT MATCHING WITH THE TROCAR. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20105668 ↗
• MalfunctionAug 28, 2024Failure to Deliver Energy; Failure to Deliver Energy

  A PHYSICIAN REPORTED THAT DURING PARS PLANA VITRECTOMY PROCEDURE, LASER SPOT COULD NOT BE PRODUCED AFTER CONNECTING AN OPHTHALMIC LASER PROBE. SURGERY WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE PROBE AND WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20084470 ↗
• MalfunctionAug 27, 2024Defective Component; Defective Component

  A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER PROBE COULD NOT ENTER THE EYE SMOOTHLY AND TIP OF THE LASER PROBE NOT SMOOTH DURING PHOTOCOAGULATION SURGERY. THE SURGERY WAS COMPLETED WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20074716 ↗
• MalfunctionAug 13, 2024Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING A VITRECTOMY, AN OPHTHALMIC LASER PROBE COULD NOT PASS THROUGH THE OPHTHALMIC TROCAR. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATIVE PRODUCT, AND THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19970290 ↗
• MalfunctionJun 17, 2024Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT DURING SURGERY, AN OPHTHALMIC LASER PROBE CANNOT BE INSERTED INTO THE TROCAR. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT IMPACT HAVE NOT BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19546504 ↗
• MalfunctionJun 3, 2024Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT AN OPHTHALMIC LASER PROBE HAD A PROTRUSION AND COULD NOT BE INSERTED IN TROCAR DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. DETAILS OF PATIENT HARM WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19450592 ↗
• MalfunctionMay 15, 2024Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT OPHTHALMIC LASER PROBE COULD NOT BE INSERTED INTO TROCAR DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH ANOTHER PROBE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319639 ↗
• MalfunctionMay 15, 2024Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT OPHTHALMIC LASER PROBE COULD NOT BE INSERTED INTO TROCAR ENTIRELY, ONLY CAN BE INSERTED HALFWAY DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH ANOTHER PROBE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319638 ↗
• MalfunctionMay 14, 2024Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT AN OPHTHALMIC LASER PROBE TIP WAS FOUND TO BE ROUGH AND CANNOT ENTER IN THE EYE SMOOTHLY BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19308095 ↗
• MalfunctionApr 29, 2024Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER PROBE DID NOT REMAIN IN THE TROCAR DURING THE SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THE PATIENT HARM AND PROCEDURE DETAILS WERE NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19210500 ↗
• MalfunctionApr 1, 2024Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC LASER FIBER CANNOT ENTER THE PUNCTURE CASING TUBE BECAUSE OF THE DIAMETER DOES NOT MATCH. PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19010282 ↗
• MalfunctionMar 25, 2024Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING PROB WOULD NOT FIT INTO THE CANNULA DURING THE SURGERY. THE SURGERY WAS COMPLETED WITH ALTERNATIVE PROBE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967796 ↗