Infiniti 8065750121Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380657501212), received between Mar 4, 2022 and Nov 28, 2023 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2023Failure to Prime; Suction Failure; Failure to Prime; Suction Failure

  A CUSTOMER REPORTED THAT AN OPHTHALMIC HANDPIECE SUCTION WAS NOT WORKING DURING A CATARACT SURGERY DURING PHACOEMULSIFICATION MODE. THE SURGERY WAS COMPLETED BY AN ALTERNATE HANDPIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18215169 ↗
• MalfunctionNov 10, 2023Partial Blockage; Decrease in Suction; Partial Blockage; Decrease in Suction

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY OPHTHALMIC HANDPIECE PRESENTED WITH OCCLUSION AND LOW ASPIRATION IN SCULPT MODE. PROCEDURE DETAILS WERE NOT REPORTED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18110438 ↗
• MalfunctionSep 29, 2023Overheating of Device; Overheating of Device

  A CUSTOMER REPORTED THAT DURING CATARACT SURGERY THE PHACOEMULSIFICATION HANDPIECE GOT HOT. THE SURGERY WAS COMPLETED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17842178 ↗
• InjuryMay 8, 2023Failure to Deliver Energy; Appropriate Device Problem Term/Code Not Available; Failure to Deliver Energy; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY AN OPHTHALMIC HANDPIECE WOULD NOT DELIVER THE PHACOEMULSIFICATION POWER AND THE HANDPIECE CONNECTOR WAS DAMAGED WITH BURN SPOTS AT THE CONNECTOR TIP. THE SURGERY WAS COMPLETED ON THE SAME DAY BY CHANGING TO THE ALTERNATIVE PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16885321 ↗
• MalfunctionApr 28, 2023Overheating of Device; Overheating of Device

  A PHYSICIAN REPORTED THAT OPHTHALMIC HANDPIECE HAS THREE HOT SPOTS AT THE SAME LATITUDE ON THE TAIL WERE FOUND. THE HANDPIECE HEAT WAS INCREASES FROM THE INSIDE OUT, AND THEN THE TEMPERATURE IS CONCENTRATED IN THREE POSITIONS OF THE HANDPIECE, RESULTING IN HOT SPOTS NO REPORT OF ANY PATIENT HARM. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831563 ↗
• InjuryDec 21, 2022Overheating of Device; Overheating of Device

  A GOVERNMENT AGENCY REPORTED THAT DURING A SURGERY A PHACOEMULSIFICATION HANDPIECE EXHIBITED INCREASE IN TEMPERATURE AND PATIENT EXPERIENCED EDEMA AROUND THE MAIN INCISION WHICH RANGED TO THE PUPIL AREA AS WELL. AFTER THE PROCEDURE PATIENT GIVEN WITH CORTICOSTEROIDS EYE DROPS. THE SYMPTOM AND VISION WERE IMPROVED IN THE SECOND DAY.

  Patient problems: Corneal Edema

  MAUDE report 16020678 ↗
• InjuryDec 14, 2022Complete Blockage; Failure to Deliver Energy; Complete Blockage; Failure to Deliver Energy

  A GOVERNMENT AGENCY REPORTED THAT AN OPHTHALMIC PHACOEMULSIFICATION HANDPIECE WAS BLOCKED AND THERE WAS NO ULTRASOUND. THE PATIENT WAS EXPERIENCED WITH CORNEAL EDEMA AND PROVIDED WITH CORTICOSTEROIDS (ORAL AND PARA OCULAR INJECTION) AND ANTI INFLAMMATORY DRUGS. ONE WEEK POST OPERATIVELY THE VISION WAS DISCOVERED AND CORNEAL EDEMA SUBSIDED.

  Patient problems: Corneal Edema

  MAUDE report 15975766 ↗
• MalfunctionMar 4, 2022Failure to Deliver Energy; Failure to Deliver Energy

  A PHYSICIAN REPORTED THAT BEFORE A CATARACT SURGERY PHACOEMULSIFICATION HANDPIECE (HP) WAS NOT GIVING POWER. SURGERY WAS COMPLETED USING ANOTHER HP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13665472 ↗