Engauge, Vektor 8065752556Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380657525560), received between Dec 24, 2021 and Apr 22, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (15 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE VITRECTOMY SURGERY AN OPHTHALMIC LASER PROBE DID NOT FIT THROUGH THE TROCAR CANULA. THE SURGERY WAS COMPLETED ON THE SAME DAY CAUSING NO IMPACT ON PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953541 ↗
• MalfunctionDec 26, 2025Defective Component; Defective Component

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC LASER PROBE COULD NOT INSERT INTO TROCAR DURING SURGERY. THE PROCEDURE TYPE WAS NOT REPORTED. NO PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 23895660 ↗
• MalfunctionSep 3, 2025Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT DURING SURGERY AN OPHTHALMIC LASER PROBE WOULD NOT FIT INTO THE TROCAR. THE PROCEDURE WAS COMPLETED BY USING ANOTHER PROBE WITHOUT PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22949335 ↗
• MalfunctionJun 9, 2025Defective Component; Defective Component

  A CUSTOMER REPORTED THAT THE DURING VITRECTOMY SURGERY AN OPHTHALMIC LASER PROBE COULD NOT GET INTO THE PUNCTURE SYSTEM. THE SURGERY WAS COMPLETED BY USING NEW PRODUCT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165443 ↗
• MalfunctionJun 3, 2025Fitting Problem; Fitting Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING VITRECTOMY SURGERY, OPHTHALMIC PROBE CANNOT BE INSERTED INTO THE PUNCTURE SYSTEM. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE NEW ONE. THE PATIENT IMPACT HAS NOT BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22131628 ↗
• MalfunctionApr 24, 2025Fitting Problem; Material Twisted/Bent; Fitting Problem; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT DURING CALIBRATION OF AN OPHTHALMIC LASER PROBE TIP WAS BENT AND DID NOT FIT INTO THE TROCAR. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. PATIENT HARM WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21897122 ↗
• MalfunctionApr 18, 2025Fitting Problem; Fitting Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT A LASER PROBE TIP THAT COULD NOT ENTER INTO TROCAR DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER A NEW REPLACEMENT WAS USED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864662 ↗
• MalfunctionFeb 3, 2025Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT IN AN OPHTHALMIC LASER PROBE, THE TIP DID NOT FIT INTO THE PORT DURING SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21297998 ↗
• MalfunctionNov 8, 2024Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT DURING VITRECTOMY SURGERY A LASER PROBE WAS ALMOST IMPOSSIBLE TO GET INSIDE THE TROCAR. THE SURGERY WAS COMPLETED WITH NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20639020 ↗
• MalfunctionSep 4, 2024Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING CATARACT AND VITRECTOMY COMBINATION SURGERY AN OPHTHALMIC LASER PROBE COULD NOT BE INSERTED INTO TROCAR. THE SURGERY WAS COMPLETED POST REPLACING THE PRODUCT WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20132265 ↗
• MalfunctionMay 24, 2024Fitting Problem; Fitting Problem

  A-CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING PROBE TIP GOT DURING THE VITRECTOMY SURGERY, HENCE IT CANNOT BE USED FOR THE PROCEDURE. 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 19389991 ↗
• MalfunctionMar 28, 2024Fitting Problem; Fitting Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, AN OPHTHALMIC LASER PROBE TROCAR INSERTION WAS STUCK. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18994079 ↗
• MalfunctionSep 13, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC OPERATING PROBE WOULD NOT INSERTED INTO THE TROCAR DURING THE 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 17735470 ↗
• MalfunctionJul 31, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT BEFORE A VITRECTOMY SURGERY AN OPHTHALMIC PROBE WAS NOT ABLE TO INSERTED INTO THE PORT. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17423517 ↗
• MalfunctionMay 15, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING A COMBINATION OF CATARACT AND VITRECTOMY PROCEDURE AN OPHTHALMIC LASER PROBE WAS UNABLE TO INSERT FROM THE PORT. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928750 ↗
• MalfunctionJan 16, 2023Fitting Problem; Fitting Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC LASER PROBE DID NOT FIT INTO THE TROCAR. THE PROCEDURE DETAILS WAS NOT PROVIDED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16173122 ↗
• MalfunctionJun 10, 2022Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING A VITRECTOMY SURGERY AN OPHTHALMIC LASER PROBE GOT STUCK AND COULD NOT GO ALL THE WAY TO THE END OF SURGERY. SURGERY WAS COMPLETED AFTER REPLACING WITH ALTERNATE PROBE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14657840 ↗
• MalfunctionDec 24, 2021Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC ILLUMINATION LASER PROBE DID NOT ENTER THE CANNULA DURING A 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 13084574 ↗