Alcon, Engauge 8065751709Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380657517091), received between Jun 3, 2022 and Aug 14, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Fitting Problem; Fitting Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT AND VITRECTOMY COMBINATION SURGERY, THE OPHTHALMIC LASER PROBE WAS NOT ABLE TO INSERT THROUGH THE PLUG. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USED MANI TROCAR TO INSERT THE LASER PROBE INTO EYE. THE PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Insufficient Information

  MAUDE report 22801568 ↗
• MalfunctionAug 15, 2024Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT BEFORE SURGERY, AN OPHTHALMIC LASER PROBE HAD DIFFICULTY TO BE PUT INTO PORT. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990649 ↗
• MalfunctionJul 26, 2024Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT BEFORE SURGERY, AN OPHTHALMIC LASER PROBE DIFFICULT TO INSERT TO THE CANNULA. THE PROCEDURE TYPE IS UNKNOWN. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE.

  Patient problems: Insufficient Information

  MAUDE report 19836647 ↗
• MalfunctionJun 7, 2024Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT PRODUCT GOT CAUGHT AND COULD NOT BE INSERTED PROPERLY DURING SURGERY. THE TYPE OF PROCEDURE WAS NOT REPORTED. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH ANOTHER PRODUCT. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19490841 ↗
• MalfunctionFeb 14, 2024Fitting Problem; Fitting Problem

  A CLINICAL NURSE REPORTED THAT AN OPHTHALMIC LASER PROBE WAS USED DURING THE COMBINATION OF CATARACT AND VITRECTOMY SURGERY AND PROBE WOULD NOT BE ABLE TO INSERT INTO THE CANNULA. THE SURGERY WAS COMPLETED WITH ALTERNATIVE PROBE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18701881 ↗
• MalfunctionDec 4, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT THE LASER COULD NOT BE INSERTED INTO THE PORT WHEN TRIED TO USE DURING CATARACT/VITRECTOMY SURGERY, WHEN TOUCHED IT TO CHECK THERE WAS A ROUGHNESS ON THE LASER TIP AND THE SHAPE WAS DEFECTIVE. THE PROCEDURE WAS COMPLETED AFTER REPLACING WITH ANOTHER ONE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255173 ↗
• MalfunctionAug 1, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING CALIBRATION SETTING FOR A CATARACT-VITRECTOMY COMBINATION SURGERY AN OPHTHALMIC PROBE GOT STUCK IN OPHTHALMIC TROCAR. THE SURGERY WAS COMPLETED USING ANOTHER PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435052 ↗
• MalfunctionJun 28, 2023Particulates; Fitting Problem; Particulates; Fitting Problem

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC LASER PROBE HAVING THE DIFFICULTY IN INSERTING THROUGH THE CANNULA AND PLASTIC MATERIAL WAS FOUND ON THE PROBE DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY USING THE ALTERNATIVE PROBE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17214418 ↗
• MalfunctionFeb 28, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC LASER COULD NOT BE INSERTED INTO TROCAR. DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE INVOLVED EYE AND THE PATIENT IDENTIFIER ARE NOT AVAILABLE. THERE'S NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16450958 ↗
• MalfunctionJan 9, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT THICKNESS OF THE TIP OF THE OPHTHALMIC LASER PROBE WAS ABNORMAL AND IT DID NOT ENTER THE PORT DURING CALIBRATION. THE PROCEDURE WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16119873 ↗
• MalfunctionAug 2, 2022Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY AN OPHTHALMIC LASER PROBE GOT CAUGHT AND COULD NOT BE INSERTED INTO THE PATIENTS' EYE. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15146637 ↗
• MalfunctionJul 14, 2022Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC LASER PROBE COULD NOT BE INSERTED INTO THE TROCAR CANNULA DURING A CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE LASER PROBE WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15012093 ↗
• MalfunctionJun 20, 2022Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC LASER PROBE WAS DIFFICULT TO INSERT INTO THE TROCAR VALVE 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 14744546 ↗
• MalfunctionJun 3, 2022Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY AN OPHTHALMIC LASER PROBE GOT STUCK IN TROCAR AND COULD NOT ENTER INTO THE EYE. 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 14594430 ↗