Laureate 8065750470Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380657504701), received between Mar 3, 2022 and Dec 24, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT, DURING ANTERIOR VITRECTOMY SURGERY AN OPHTHALMIC HANDPIECE DIDN'T CUT, AND NO CUTTING SOUND WAS HEARD. IT IS UNKNOWN WHETHER THE SURGERY WAS COMPLETED. PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 23886697 ↗
• MalfunctionAug 25, 2024Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT BEFORE VITRECTOMY SURGERY AN OPHTHALMIC OPERATING HANDPIECE NOT CUTTING. THE SURGERY WAS COMPLETED ON THE SAME DAY BY AN ALTERNATIVE PROCEDURE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20061072 ↗
• MalfunctionMar 26, 2024Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT AN OPHTHALMIC HANDPIECE HAD NO CUTTING IN VITRECTOMY MODE IN CATARACT SURGERY. DETAILS OF PROCEDURE WERE NOT REPORTED. THERE WAS NO PATIENT HARM. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18976986 ↗
• MalfunctionMar 6, 2024Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT DURING CATARACT PROCEDURE OPHTHALMIC HANDPIECE WAS NOT CUTTING. THE PROCEDURE COMPLETED BY REPLACING WITH ANOTHER HANDPIECE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18844490 ↗
• MalfunctionOct 20, 2023Overheating of Device; Failure to Cut; Overheating of Device; Failure to Cut

  A CUSTOMER REPORTED THAT OPHTHALMIC HANDPIECE VITRECTOMY CUTTING WAS NONE AND HANDPIECE WAS GETTING HOT. THE INCIDENT WAS OBSERVED BEFORE SURGERY. THERE WAS NOT DETAILS OF PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17975272 ↗
• MalfunctionSep 4, 2023Overheating of Device; Overheating of Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC HANDPIECE DID NOT WORK AND IT BECAME HOT. PROCEDURE COMPLETED DETAILS AND PATIENT IMPACT DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17676627 ↗
• MalfunctionAug 1, 2023Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING HANDPIECE WOULD NOT CUT IN VITRECTOMY MODE. THE PROCEDURE DETAILS AND PATIENT HARM DETAILS WERE NOT PROVIDED. ADDITIONAL INFORMATION RECEIVED THAT DURING THE VITRECTOMY SURGERY THE OPHTHALMIC OPERATING HANDPIECE WOULD NOT PERFORM THE CUTTING ACTION. SURGERY WAS COMPLETED WITH MANUAL VITRECTOMY AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17434930 ↗
• MalfunctionApr 4, 2023Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT DURING A VITRECTOMY SURGERY AN OPHTHALMIC VITRECTOMY HANDPIECE DID NOT CUT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16672327 ↗
• MalfunctionJan 19, 2023Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT DURING A VITRECTOMY WHILE USING HANDPIECE THE VITRECTOMY CUTTING WAS NOT THERE. SURGERY WAS COMPLETED BY USING ANOTHER PRODUCT. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16205041 ↗
• MalfunctionNov 22, 2022Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY THE VITRECTOMY CUTTER DID NOT WORK, THE PROCEDURE WAS COMPLETED BY USING THE STANDBY MACHINE, THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15843350 ↗
• MalfunctionApr 22, 2022Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT BEFORE A CATARACT SURGERY AN OPHTHALMIC VITRECTOMY HANDPIECE WAS NOT WORKING. SURGERY WAS COMPLETED BY REPLACING THE HANDPIECE WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189453 ↗
• MalfunctionMar 3, 2022Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT WHILE USING AN OPHTHALMIC CONSOLE VITRECTOMY HANDPIECE WAS NOT WORKING. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13657894 ↗