Alcon, Engauge 8065750991Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380657509911), received between May 10, 2021 and Dec 29, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Defective Component; Defective Component

  A PHYSICIAN REPORTED THAT DURING THE VITRECTOMY, OPHTHALMIC LASER PROBE TIP COULD NOT BE INSERTED INTO THE TROCAR CANNULA. THE ENERGY OF LASER PROBE HASN'T BEEN TESTED BECAUSE THE LASER PROBE COULD NOT BE INSERTED, CONNECTION TO DEVICE AND TEST WERE NORMAL. AFTER REPLACING WITH A NEW LASER PROBE, THE SURGERY WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905220 ↗
• MalfunctionJan 21, 2025Difficult to Insert; Difficult to Insert

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY AN OPHTHALMIC LASER PROBE EXHIBITED THAT THE TIP CANNOT BE INSERTED INTO THE EYE FOR LASER TREATMENT. THE SURGERY WAS COMPLETED POST REPLACING THE LASER PROBE. INFORMATION REGARDING PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21194525 ↗
• MalfunctionDec 17, 2024Difficult to Insert; Difficult to Insert

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY, THE LASER PROBE TIP COULD NOT BE INSERTED INTO THE EYE FOR LASER TREATMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE LASER PROBE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20950724 ↗
• MalfunctionJul 31, 2024Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT PROBE DID NOT FIT INTO THE TROCHANTER, IT PROBABLY CAME WITHOUT TIPS. PATIENT AND PROCEDURE DETAILS WERE NOT REPORTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19870430 ↗
• MalfunctionJul 9, 2024Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC LASER PROBE TIP COULD NOT ENTER INTO THE EYE AND THE LASER COULD NOT BE PERFORMED. SURGERY WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE PRODUCT. PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19699625 ↗
• MalfunctionFeb 9, 2023Fitting Problem; Defective Component; Fitting Problem; Defective Component

  A CUSTOMER REPORTED THAT DURING A SURGERY IT WAS NOTED THAT THE TIP OF AN OPHTHALMIC LASER PROBE WAS DEFECTIVE AND IT DOES NOT FIT INTO THE OPHTHALMIC TROCAR. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED CLARIFYING THAT THE ISSUE HAPPENED DURING VITRECTOMY AND THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16331928 ↗
• MalfunctionFeb 3, 2023Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT AN OPHTHALMIC LASER PROBE WAS NOT ENTERING INTO THE TROCAR BEFORE SURGERY. PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16295675 ↗
• MalfunctionAug 6, 2022Crack; Fitting Problem; Crack; Fitting Problem

  A CUSTOMER REPORTED THAT AN OPHTHALMIC PROBE HAD CRACK IN THE TIP WHICH MADE IT IMPOSSIBLE TO FIT INTO THE TROCAR. THE DETAILS ABOUT PATIENT IMPACT WERE NOT PROVIDED. ADDITIONAL INFORMATION CANNOT BE OBTAINED AS THE REPORTER IS UNWILLING TO PROVIDE FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15180541 ↗
• MalfunctionDec 8, 2021Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT AN OPHTHALMIC LASER PROBE COULD NOT ENTER THE VALVE CANNULA DURING A PHOTOCOAGULATION PROCEDURE. THE PROCEDURE WAS COMPETED SUCCESSFULLY AFTER REPLACING THE LASER PROBE WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12961390 ↗
• MalfunctionMay 10, 2021Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT THE LASER PROBE DOES NOT FIT THROUGH THE CANNULA PORTS. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT EVENT OCCURRED DURING POSTERIOR VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY DISCONNECTING THE LASER PROBE AND CONNECTING ANOTHER LASER PROBE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795768 ↗