Alcon, Engauge 8065750978Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380657509782), received between Jun 17, 2021 and Dec 11, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2023Accessory Incompatible; Accessory Incompatible

  A PHYSICIAN REPORTED THAT BEFORE VITRECTOMY SURGERY A LASER PROBE COULD NOT ACCESS TO TROCAR CANNULA. THE SURGERY WAS COMPLETED AFTER REPLACING AND PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18299971 ↗
• MalfunctionOct 17, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT THE OPHTHALMIC TIP WAS FOUND UNEVEN, THEREFORE, TAKING IN AND OUT TO THE PORT WAS NOT SMOOTH DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE INVOLVED EYE AND THE PATIENT IDENTIFIER WERE NOT AVAILABLE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17947200 ↗
• MalfunctionAug 17, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING THE VITRECTOMY SURGERY, OPHTHALMIC PROBE COULD NOT BE INSERTED INTO THE TROCAR AND COULD NOT BE USED DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE INVOLVED EYE AND THE PATIENT IDENTIFIER WERE NOT AVAILABLE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17565033 ↗
• MalfunctionJul 27, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT THE TIP WAS BUMPY, THEREFORE, THE SHAFT COULD NOT BE INSERTED INTO 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 17403741 ↗
• MalfunctionJul 5, 2023Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT DURING THE VITRECTOMY SURGERY, OPHTHALMIC LASER PROBE DID NOT MATCH THE TROCAR AND THE SURGERY WAS COMPLETED AFTER A NEW REPLACEMENT WAS USED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17254316 ↗
• MalfunctionJan 4, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING A COMBINATION OF CATARACT AND VITRECTOMY PROCEDURE AN OPHTHALMIC LASER PROBE WAS STUCK DURING PORT INSERTION. SURGERY WAS COMPLETED USING ANOTHER PROBE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095298 ↗
• MalfunctionAug 5, 2022Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING A CATARACT/VITRECTOMY COMBINATION SURGERY OPHTHALMIC LASER DID NOT GET INTO THE TROCAR. THE SHAFT WAS BENT. 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 15179840 ↗
• MalfunctionNov 8, 2021Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY THE LASER PROBE COULD NOT ACCESS THROUGH THE TROCAR AT THE TIME OF PHOTOCOAGULATION. PATIENT HARM WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12768883 ↗
• MalfunctionJun 17, 2021Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING A COMBINATION CATARACT AND VITRECTOMY SURGERY, AN OPHTHALMIC LASER PROBE COULD NOT BE INSERTED INTO THE TROCAR. AN ALTERNATE LASER PROBE WAS OBTAINED IN ORDER TO COMPLETE THE SURGERY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12021033 ↗