Alcon 8065752180Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 00380657521807), received between Apr 2, 2021 and Sep 23, 2026 — classified as 2 injuries, 111 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (38 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 25 most recent of 113 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Suction Problem

  A nurse reported that the vacuum reading did not increase and no suction was generated during the surgery. The procedure type was unknown. The surgery was completed on the same day. There was no information about patient impact.Additional information received that vacuum reading did not increase and no suction was generated during phacoemulsification mode.

  Patient problems: Insufficient Information

  MAUDE report 50869745 ↗
• MalfunctionSep 23, 2026Incomplete or Inadequate Connection

  A healthcare professional reported that the error code ¿ loose tip issue displayed before surgery. The surgery was completed on same day, after replacing the phacoemulsification tip with another one. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50867415 ↗
• MalfunctionMay 18, 2026Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT CUTTER FAILED TO PERFORM CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25200296 ↗
• MalfunctionApr 15, 2026Suction Problem

  A CUSTOMER REPORTED THAT THE CASSETTE STOPPED WORKING, THE HANDPIECES WERE NOT ASPIRATING (DUE TO THE PACK ISSUE) DURING CATARACT SURGERY (WITHOUT INTRAOCULAR LENSES IMPLANT). THE SURGERY WAS COMPLETED ON SAME DAY, AFTER REPLACING THE PRODUCT. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24884563 ↗
• MalfunctionApr 7, 2026Suction Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT NO SUCTION ON PHACOEMULSIFICATION MODE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY DETAILS AND PATIENT IMPACT DETAILS WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24797229 ↗
• MalfunctionMar 17, 2026Suction Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT NO SUCTION DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS PERFORMED AND COMPLETED ON THE SAME DAY BUT IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO INFORMATION ABOUT THE PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24614874 ↗
• MalfunctionMar 11, 2026Infusion or Flow Problem

  A HEALTH CARE PROFESSIONAL IRRIGATION FAILED DURING QUADRANT REMOVAL OF CATARACT SURGERY (WITH INTRAOCULAR LENSES IMPLANT). THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACING IT WITH A NEW PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574424 ↗
• MalfunctionMar 3, 2026Air/Gas in Device

  A NURSE REPORTED THAT AIR WAS OBSERVED IN THE IRRIGATION LINE DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANTATION) WHERE THESE BUBBLES PARTIALLY OBSCURED THE SURGICAL FIELD, AND THE SURGEON FELT THAT THE PROCEDURE BECAME MORE DIFFICULT AS A RESULT. HOWEVER, THE SURGERY WAS COMPLETED NORMALLY BY REPLACING THE PACK WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496005 ↗
• MalfunctionJan 23, 2026Infusion or Flow Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT PACK HAD NO REACTION TO IRRIGATION DURING INTRAOCULAR LENS IMPLANTATION. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH NEW PACK. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24159262 ↗
• MalfunctionJan 14, 2026Suction Problem

  A NURSE REPORTED THAT WHEN USING PHACOEMULSIFICATION MODE, THE VACUUM DID NOT WORK DURING THE SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BUT REPLACEMENT DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24065064 ↗
• MalfunctionJan 13, 2026Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE CUTTER WAS UNABLE TO CUT THE FILTER BEFORE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052160 ↗
• MalfunctionDec 23, 2025Suction Problem; Suction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874979 ↗
• MalfunctionDec 23, 2025Suction Failure; Suction Failure

  ADDITIONAL NEW INFORMATION WAS RECEIVED THAT THE EVENT OCCURRED DURING THE PHACO EMULSIFICATION MODE OF THE CATARACT SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 23874453 ↗
• MalfunctionDec 22, 2025Suction Problem; Suction Problem

  A CUSTOMER REPORTED THAT THE SUCTION LOST DURING INTRAOCULAR LENS IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY, BUT UNKNOWN HOW IT WAS COMPLETED. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23861483 ↗
• MalfunctionDec 18, 2025Suction Problem; Suction Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT WATER CHAMBER HAD COMPLETED PRIME BUT LOSES SUCTION DURING INTRAOCULAR LENS IMPLANT SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED ON SAME DAY. THERE WAS NO INFORMATION ABOUT THE PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23838754 ↗
• MalfunctionDec 11, 2025Material Separation; Material Separation

  A NURSE REPORTED THAT THE SOLUTION LINE DISLODGES FROM HANDPIECE DURING INTRAOCULAR LENS IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23786198 ↗
• MalfunctionDec 9, 2025Obstruction of Flow; Obstruction of Flow

  A GOVERNMENT AGENCY REPORTED THAT, DURING EXTRACAPSULAR CATARACT EXTRACTION FOLLOWED BY PHACOEMULSIFICATION AND INTRAOCULAR LENS IMPLANTATION, AN OPHTHALMIC HANDPIECE DID NOT PROVIDE SUCTION AND BECAME HOT. SURGERY WAS COMPLETED BY REPLACING THE HANDPIECE WITH ANOTHER SET. THERE WAS NO PATIENT HARM. THIS REPORT PERTAINS TO PHACO EMULSIFICATION TIP (PHACO TIP) INVOLVED IN REPORTED EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23753994 ↗
• MalfunctionNov 28, 2025Suction Problem; Infusion or Flow Problem; Suction Problem; Infusion or Flow Problem

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT IRRIGATION AND ASPIRATION (I/A) UNABLE TO IRRIGATE OR ASPIRATE DURING CATARACT SURGERY WITHOUT INTRAOCULAR LENS IMPLANT (IOL). THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23671500 ↗
• MalfunctionNov 18, 2025Suction Problem; Suction Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS NO SUCTION DURING INTRAOCULAR LENS IMPLANTATION SURGERY. THE OTHER SURGERY DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23579307 ↗
• MalfunctionNov 7, 2025Suction Problem; Suction Problem

  A NURSE REPORTED THAT KIT HAD A SURGE EFFECT AND DEFECTIVE DURING CATARACT WITHOUT INTRAOCULAR LENS IMPLANT SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23495665 ↗
• MalfunctionOct 15, 2025Suction Problem; Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT ASPIRATION ERROR OCCURRED DURING CATARACT SURGERY (WITH INTRAOCULAR LENSES IMPLANT). THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23299173 ↗
• MalfunctionOct 12, 2025Obstruction of Flow; Obstruction of Flow

  A HEALTHCARE PROFESSIONAL REPORTED THAT CASSETTE WAS CLOGGING DURING VISCO REMOVAL MODE OF INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY. THE OTHER SURGERY DETAILS WERE UNKNOWN. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23275848 ↗
• MalfunctionOct 12, 2025Suction Problem; Suction Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE VACUUM STOPPED WORKING DURING PHACOEMULSIFICATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. ALTHOUGH THERE WAS A DELAY AND IT TOOK LONGER TIME THAN EXPECTED, THE SURGERY WAS COMPLETED ON THE SAME DAY BY INCREASING THE VACUUM AND USING ANOTHER OPHTHALMIC VISCOELASTIC DEVICE TO RULE OUT THE PROBLEM. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23275602 ↗
• MalfunctionOct 12, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT THERE WAS CLOGGING DURING VISCO ELASTIC MATERIAL REMOVAL (IN VISCO MODE) POST INTRA OCULAR LENS IMPLANTATION DURING CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION) RESULTING IN A FAILURE OF ASPIRATION. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23274548 ↗
• MalfunctionSep 18, 2025Suction Problem; Suction Problem

  A OTHER HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS NO VACUUM DURING THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER CASSETTE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23081702 ↗