Alcon 8065752200Recalls & reported problems

Summary

The FDA's MAUDE database contains 366 adverse event reports that list this exact device (DI 00380657522002), received between Mar 9, 2021 and Sep 30, 2026 — classified as 44 injuries, 322 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (78 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 28, 2023Open, Classified

   Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

   Z-2407-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 366 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Obstruction of Flow

  A physician reported that there was water blockage during surgery. The procedure type was unknown, and the surgery was completed on the same day after replacing the product with a new one. There was a patient contact but there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943557 ↗
• MalfunctionSep 30, 2026Suction Problem

  A physician reported that there was a blockage during cataract surgery (with intraocular lens implant) in irrigation/aspiration mode. The surgery was completed on the same day using the same product. There was a patient contact but there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943433 ↗
• MalfunctionAug 14, 2026Suction Problem

  Patient problems: Insufficient Information

  MAUDE report 50249316 ↗
• MalfunctionAug 13, 2026Suction Problem; Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50235077 ↗
• MalfunctionAug 12, 2026Suction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222638 ↗
• MalfunctionAug 12, 2026Product Quality Problem

  The other health care professional reported that there was foreign body noted in the phaco sleeve plastic like shape during surgery. The procedural type was unknown. The Surgery completed however the replacement details were unknown. There was no patient impact

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218445 ↗
• MalfunctionJun 8, 2026

  PLASTIC TUBING CONNECTION WOULDN'T COME APART AFTER PRIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428749 ↗
• MalfunctionApr 20, 2026Suction Problem

  A NURSE REPORTED THAT CASSETTE DID NOT ASPIRATE DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF CASSETTE WITH NEW ONE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24922447 ↗
• MalfunctionApr 15, 2026Suction Problem

  A NURSE REPORTED THAT ASPIRATION WAS NOT WORKING DURING THE SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY. THE OTHER SURGERY DETAILS AND PATIENT DETAILS WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24885045 ↗
• MalfunctionMar 30, 2026Suction Problem

  A PHARMACIST REPORTED THAT LOSS OF SUCTION OCCURRED DURING THE PHACOEMULSIFICATION PHASE DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING THE SECOND CASSETTE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24711373 ↗
• MalfunctionMar 26, 2026Incomplete or Inadequate Connection

  A PHYSICIAN REPORTED THAT THE TIP WAS LOOSE DURING CALIBRATION. THE PROCEDURE TYPE AND SURGERY COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699440 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS SUSPECTED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WHICH WAS A SIGNIFICANT INTRAOCULAR REACTION FOLLOWING A CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION) IN AN ELDERLY PATIENT. THE SURGERY COMPLETION DETAILS OR CURRENT PATIENT CONDITION WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 24597196 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS SUSPECTED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WHICH WAS A SIGNIFICANT INTRAOCULAR REACTION FOLLOWING A CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION) IN AN ELDERLY PATIENT. THE SURGERY COMPLETION DETAILS OR CURRENT PATIENT CONDITION WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE. THIS REPORT BELONGS TO THE EIGHTH OF THE NINE PATIENTS REPORTED WITH SAID ADVERSE EVENT FROM THE SAME FACILITY.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 24596748 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS SUSPECTED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WHICH WAS A SIGNIFICANT INTRAOCULAR REACTION FOLLOWING A CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION) IN AN ELDERLY PATIENT. THE SURGERY COMPLETION DETAILS OR CURRENT PATIENT CONDITION WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE. THIS REPORT BELONGED TO FIRST OF THE NINE PATIENTS REPORTED WITH SAID ADVERSE EVENT FROM THE SAME FACILITY.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 24596727 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS SUSPECTED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WHICH WAS A SIGNIFICANT INTRAOCULAR REACTION FOLLOWING A CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION) IN AN ELDERLY PATIENT. THE SURGERY COMPLETION DETAILS OR CURRENT PATIENT CONDITION WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE. THIS REPORT BELONGS TO THE SIXTH OF THE NINE PATIENTS REPORTED WITH SAID ADVERSE EVENT FROM THE SAME FACILITY.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 24596726 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS SUSPECTED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WHICH WAS A SIGNIFICANT INTRAOCULAR REACTION FOLLOWING A CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION) IN AN ELDERLY PATIENT. THE SURGERY COMPLETION DETAILS OR CURRENT PATIENT CONDITION WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE. THIS REPORT BELONGED TO THE SECOND OF THE NINE PATIENTS REPORTED WITH SAID ADVERSE EVENT FROM THE SAME FACILITY.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 24596699 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS SUSPECTED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WHICH WAS A SIGNIFICANT INTRAOCULAR REACTION FOLLOWING A CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION) IN AN ELDERLY PATIENT. THE SURGERY COMPLETION DETAILS OR CURRENT PATIENT CONDITION WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE. THIS REPORT BELONGED TO FIRST OF THE NINE PATIENTS REPORTED WITH SAID ADVERSE EVENT FROM THE SAME FACILITY.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 24596697 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS SUSPECTED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WHICH WAS A SIGNIFICANT INTRAOCULAR REACTION FOLLOWING A CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION) IN AN ELDERLY PATIENT. THE SURGERY COMPLETION DETAILS OR CURRENT PATIENT CONDITION WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 24593832 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS SUSPECTED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WHICH WAS A SIGNIFICANT INTRAOCULAR REACTION FOLLOWING A CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION) IN AN ADULT PATIENT. THE SURGERY COMPLETION DETAILS OR CURRENT PATIENT CONDITION WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE. THIS REPORT BELONGED TO THE SEVENTH OF THE NINE PATIENTS REPORTED WITH SAID ADVERSE EVENT FROM THE SAME FACILITY.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 24593323 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS SUSPECTED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WHICH WAS A SIGNIFICANT INTRAOCULAR REACTION FOLLOWING A CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION) IN AN ELDERLY PATIENT. THE SURGERY COMPLETION DETAILS OR CURRENT PATIENT CONDITION WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE. THIS REPORT BELONGS TO THE EIGHTH OF THE NINE PATIENTS REPORTED WITH SAID ADVERSE EVENT FROM THE SAME FACILITY.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 24593318 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS SUSPECTED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WHICH WAS A SIGNIFICANT INTRAOCULAR REACTION FOLLOWING A CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION) IN AN ELDERLY PATIENT. THE SURGERY COMPLETION DETAILS OR CURRENT PATIENT CONDITION WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE. THIS REPORT BELONGS TO THE FOURTH OF THE NINE PATIENTS REPORTED WITH SAID ADVERSE EVENT FROM THE SAME FACILITY.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 24593265 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS SUSPECTED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WHICH WAS A SIGNIFICANT INTRAOCULAR REACTION FOLLOWING A CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION) IN AN ELDERLY PATIENT. THE SURGERY COMPLETION DETAILS OR CURRENT PATIENT CONDITION WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 24590083 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS SUSPECTED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WHICH WAS A SIGNIFICANT INTRAOCULAR REACTION FOLLOWING A CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION) IN AN ELDERLY PATIENT. THE SURGERY COMPLETION DETAILS OR CURRENT PATIENT CONDITION WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 24590080 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS SUSPECTED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WHICH WAS A SIGNIFICANT INTRAOCULAR REACTION FOLLOWING A CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION) IN AN ELDERLY PATIENT. THE SURGERY COMPLETION DETAILS OR CURRENT PATIENT CONDITION WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 24589031 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS SUSPECTED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WHICH WAS A SIGNIFICANT INTRAOCULAR REACTION FOLLOWING A CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION) IN AN ELDERLY PATIENT. THE SURGERY COMPLETION DETAILS OR CURRENT PATIENT CONDITION WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 24589030 ↗