Infinit, Microsmooth, Alcon 8065750517Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380657505173), received between Oct 19, 2021 and Jan 1, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 1, 2024Leak/Splash; Leak/Splash

  A PHARMACIST REPORTED THAT THE LEAK WAS OBSERVED AT THE BASE OF THE SLEEVE DURING THE CATARACT WITH INTRAOCULAR LENS IMPLANT SURGERY. THE PROCEDURE WAS COMPLETED AFTER THE SLEEVE WAS REPLACED WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18423079 ↗
• MalfunctionDec 27, 2023Break; Infusion or Flow Problem; Break; Infusion or Flow Problem

  AS A RESULT OF AN INTERNAL REVIEW OF THE FILE, IT WAS DETERMINED THAT THE REPORTED PRODUCT ISSUE FOOT SWITCH CABLE AGED CAUSING VALVE DAMAGE AND INABILITY TO PERFUSION DOES NOT REPRESENT A REPORTABLE MALFUNCTION AS PER APPLICABLE MEDICAL DEVICE REGULATIONS. THERE IS NO EVIDENCE OF A LIFE-THREATENING INJURY/ILLNESS OR PERMANENT IMPAIRMENT/DAMAGE, THERE HAS BEEN NO MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT/DAMAGE AND THE INFORMATION PROVIDED DOES NOT REPRESENT A PRODUCT PROBLEM THAT IS LIKELY TO CAUSE THE ABOVE-MENTIONED EVENTS IF THE PRODUCT PROBLEM WERE TO RECUR.

  Patient problems: Insufficient Information

  MAUDE report 18396128 ↗
• MalfunctionDec 26, 2023Suction Failure; Suction Failure

  A CUSTOMER REPORTED THAT THE CONTROL OF PHACOEMULSIFICATION ENERGY SUCTION FAILED, RESULTING IN AN EXTENDED SURGICAL TIME AND INCREASED INTRAOPERATIVE RISK DURING CATARACT SURGERY (WITH INTRAOCULAR LENSES IMPLANT). THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18393293 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT OPHTHALMIC OPERATING CONSOLE, HANDPIECE AND TIP WAS USED DURING THE PROCEDURE WHICH CAUSED THE THERMAL INJURY WHICH REQUIRE THE SUTURES. PATIENT CURRENT CONDITION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED STATING THAT PATIENT HAD A CORNEAL LEAK DURING THE CATARACT SURGERY WHICH COVERED WITH SEALANT.

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

  MAUDE report 16563417 ↗
• MalfunctionNov 19, 2021Break; Material Discolored; Infusion or Flow Problem; Material Too Soft/Flexible; Break; Material Discolored; Infusion or Flow Problem; Material Too Soft/Flexible

  A HEALTHCARE PROFESSIONAL REPORTED THE SLEEVES WERE NOT THE SAME AS THEY HAD DIFFERENT SHADES OF COLOR, THE LIGHTER ONES WERE THINNER, BROKE MORE EASILY WHEN THEY WERE BEING PLACED IN THE PHACOEMULSIFICATION (PHACO) NEEDLES, GET CURLED ESPECIALLY WHEN TRYING TO ENTER THE INCISION, AND THERE WAS A SIGNIFICANT REDUCTION IN INFUSION INTO THE EYES. THERE WAS NO PATIENT HARMS REPORTED. THIS IS ONE OF MULTIPLE REPORTS FOR THESE REPORTED EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843923 ↗
• MalfunctionNov 19, 2021Break; Material Discolored; Infusion or Flow Problem; Material Too Soft/Flexible; Break; Material Discolored; Infusion or Flow Problem; Material Too Soft/Flexible

  A HEALTHCARE PROFESSIONAL REPORTED THE SLEEVES WERE NOT THE SAME AS THEY HAD DIFFERENT SHADES OF COLOR, THE LIGHTER ONES WERE THINNER, BROKE MORE EASILY WHEN THEY WERE BEING PLACED IN THE PHACOEMULSIFICATION (PHACO) NEEDLES, GET CURLED ESPECIALLY WHEN TRYING TO ENTER THE INCISION, AND THERE WAS A SIGNIFICANT REDUCTION IN INFUSION INTO THE EYES. THERE WAS NO PATIENT HARMS REPORTED. THIS IS ONE OF MULTIPLE REPORTS FOR THESE REPORTED EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843918 ↗
• MalfunctionNov 19, 2021Break; Material Discolored; Infusion or Flow Problem; Material Too Soft/Flexible; Break; Material Discolored; Infusion or Flow Problem; Material Too Soft/Flexible

  A HEALTHCARE PROFESSIONAL REPORTED THE SLEEVES WERE NOT THE SAME AS THEY HAD DIFFERENT SHADES OF COLOR, THE LIGHTER ONES WERE THINNER, BROKE MORE EASILY WHEN THEY WERE BEING PLACED IN THE PHACOEMULSIFICATION (PHACO) NEEDLES, GET CURLED ESPECIALLY WHEN TRYING TO ENTER THE INCISION, AND THERE WAS A SIGNIFICANT REDUCTION IN INFUSION INTO THE EYES. THERE WAS NO PATIENT HARMS REPORTED. THIS IS ONE OF MULTIPLE REPORTS FOR THESE REPORTED EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843829 ↗
• MalfunctionNov 19, 2021Break; Material Discolored; Infusion or Flow Problem; Material Too Soft/Flexible; Break; Material Discolored; Infusion or Flow Problem; Material Too Soft/Flexible

  A HEALTHCARE PROFESSIONAL REPORTED THE SLEEVES WERE NOT THE SAME AS THEY HAD DIFFERENT SHADES OF COLOR, THE LIGHTER ONES WERE THINNER, BROKE MORE EASILY WHEN THEY WERE BEING PLACED IN THE PHACOEMULSIFICATION (PHACO) NEEDLES, GET CURLED ESPECIALLY WHEN TRYING TO ENTER THE INCISION, AND THERE WAS A SIGNIFICANT REDUCTION IN INFUSION INTO THE EYES. THERE WAS NO PATIENT HARMS REPORTED. THIS IS ONE OF MULTIPLE REPORTS FOR THESE REPORTED EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843810 ↗
• MalfunctionOct 19, 2021Break; Material Discolored; Infusion or Flow Problem; Material Too Soft/Flexible; Break; Material Discolored; Infusion or Flow Problem; Material Too Soft/Flexible

  A HEALTHCARE PROFESSIONAL REPORTED SEVERAL CUSTOMERS INDICATED TWO SLEEVES WERE NOT THE SAME AS THEY HAD DIFFERENT SHADES OF COLOR, THE LIGHTER ONES WERE THINNER, BROKE MORE EASILY WHEN THEY WERE BEING PLACED IN THE PHACOEMULSIFICATION(PHACO) NEEDLES, GET CURLED ESPECIALLY WHEN TRYING TO ENTER THE INCISION, AND THERE WAS A SIGNIFICANT REDUCTION IN INFUSION INTO THE EYES. THERE WAS NO PATIENT HARMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657721 ↗