Engauge, Vektor 8065752555Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380657525553), received between Feb 18, 2022 and Dec 12, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Defective Component; Defective Component

  A NURSE REPORTED THAT DURING THE VITRECTOMY SURGERY, OPHTHALMIC LASER PROBE COULD NOT GO THROUGH THE TROCAR CANNULA, BUT VITRECTOMY PROBE COULD GO THROUGH THE CANNULA. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER LASER PROBE. PATIENT IMPACT HAS NOT BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23790200 ↗
• MalfunctionDec 5, 2025Defective Component; Defective Component

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC LASER PROBE COULD NOT BE ADVANCED INTO THE TROCAR CANNULA. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING REPLACEMENT. THE PATIENT IMPACT HAVE NOT BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23726083 ↗
• MalfunctionFeb 18, 2025Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC LASER PROBE TIP WAS BENT AND DID NOT FIT INTO TROCAR VALVE DURING SURGERY. SURGERY WAS COMPLETED AFTER REPLACING THE PROBE WITH ANOTHER ONE. THERE WAS NO PATIENT HARM REPORTED. PROCEDURE DETAILS HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400652 ↗
• MalfunctionJan 8, 2025Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT THE OPHTHALMIC LASER PROBE GOT STUCK INSIDE TROCAR DURING CATARACT / VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21099725 ↗
• MalfunctionSep 4, 2024Failure to Fire; Failure to Fire

  A NURSE REPORTED THAT THE OPHTHALMIC LASER PROBE WAS NOT DELIVERING LASER ENERGY AND THAT NO LASER SPOT WAS VISIBLE BEFORE THE CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED AND THERE WAS NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20133183 ↗
• MalfunctionJul 4, 2024Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT ACTUATING FAILURE OF PROBE WAS CONFIRMED DURING VITRECTOMY SURGERY. THE CONDITION OF ASPIRATING WAS UNKNOWN. 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 19674050 ↗
• MalfunctionApr 12, 2024Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER PROBE HAD PULLED OUT TROCARS. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 19096501 ↗
• MalfunctionApr 1, 2024Fitting Problem; Output below Specifications; Fitting Problem; Output below Specifications

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC CONSOLE HAD WEAK POWER AND LASER DID NOT FIT BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. DETAILS OF PATIENT HARM WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19010165 ↗
• MalfunctionAug 11, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT PROBE COULD NOT BE INSERTED INTO THE OPHTHALMIC TROCAR. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17510825 ↗
• MalfunctionFeb 18, 2022Fitting Problem; Material Twisted/Bent; Fitting Problem; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT DURING A COMBINATION OF CATARACT-VITRECTOMY PROCEDURE, THE TIP OF AN OPHTHALMIC LASER PROBE WAS BENT AND COULD NOT BE INSERTED INTO THE TROCAR. THE SURGERY WAS COMPLETED AFTER REPLACING THE LASER PROBE WITH ANOTHER ONE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13556528 ↗