Infiniti 8065750157Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380657501571), received between Apr 7, 2021 and Oct 23, 2025 — classified as 10 malfunctions.

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

• MalfunctionOct 23, 2025Failure to Cut; Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT CUTTER WAS NOT CUTTING BEFORE INTRAOCULAR LENS IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY, AND IT WAS UNKNOWN HOW SURGERY GOT COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23370015 ↗
• MalfunctionJul 15, 2024Break; Break

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT ULTRA IRRIGATION HOSES HAD BROKEN DURING CATARACT SURGERY WITHOUT INTRAOCULAR LENS IMPLANT. SURGERY COMPLETION WAS UNKNOWN. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19744310 ↗
• MalfunctionApr 25, 2022Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THE CUTTING OF THE CUTTER WAS POOR DURING A CATARACT PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192098 ↗
• MalfunctionMar 8, 2022Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THE BLADES DID NOT CUT DURING A PROCEDURE. THE PROCEDURE AND PATIENT IMPACT DETAILS WERE NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13692031 ↗
• MalfunctionMar 2, 2022Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THE VITRECTOMY BLADE DID NOT CUT DURING A VITRECTOMY PROCEDURE. ASPIRATION STATUS WAS NOT REPORTED. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE INDICATED THE EVENT OCCURRED DURING THE PHACOEMULSIFICATION PHASE OF THE CATARACT PROCEDURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13649122 ↗
• MalfunctionDec 1, 2021Failure to Cut; Failure to Cut

  A NURSE REPORTED THE PROBE WAS NOT WORKING AND AFTER REPRIMING, IT DID NOT CUT AND AN OCCLUSION MESSAGE WAS DISPLAYED, THEN SECOND PROBE WAS OBTAINED AND AFTER A FEW MINUTES, IT WAS CUTTING INTERMITTENTLY DURING AN ANTERIOR VITRECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE OPHTHALMIC CONSOLE WITH A DIFFERENT ONE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED INDICATING THE PRODUCT SAMPLE WAS DISCARDED. THIS REPORT IS FOR THE FIRST PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12906345 ↗
• MalfunctionDec 1, 2021Failure to Cut; Failure to Cut

  A NURSE REPORTED THE PROBE WAS NOT WORKING AND AFTER REPRIMING, IT DID NOT CUT AND AN OCCLUSION MESSAGE WAS DISPLAYED, THEN SECOND PROBE WAS OBTAINED AND AFTER A FEW MINUTES, IT WAS CUTTING INTERMITTENTLY DURING AN ANTERIOR VITRECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE OPHTHALMIC CONSOLE WITH A DIFFERENT ONE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED INDICATING THE PRODUCT SAMPLE WAS DISCARDED. THIS REPORT IS FOR THE SECOND PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12906339 ↗
• MalfunctionNov 4, 2021Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THE VITRECTOMY PROBE HAD A CUTTING FAILURE AND THE ASPIRATION CONDITION WAS UNKNOWN DURING A SURGERY. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752375 ↗
• MalfunctionApr 28, 2021Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A CUSTOMER REPORTED THE VITRECTOMY PROBE WAS NOT CUTTING PROPERLY AND IT WAS NOT ASPIRATING PROPERLY DURING A CATARACT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740865 ↗
• MalfunctionApr 7, 2021Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT CUTTER WAS BLUNT DURING SURGERY. THE CONDITION OF ASPIRATION AND ACTUATION WAS UNKNOWN. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE IS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11629870 ↗