Alcon 00380650001344Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00380650001344), received between Jan 3, 2023 and Mar 19, 2025 — classified as 5 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2025Suction Problem; Suction Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT THE CASSETTE DID NOT BUILD VACUUM DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THE PROCEDURE WAS COMPLETED BY REPLACING THE CASSETTE WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21640670 ↗
• MalfunctionFeb 11, 2025Suction Failure; Suction Failure

  A CUSTOMER REPORTED THAT RUNNING UP THE CODE, NO VACUUM AND AIR FILLING UP THE BIG DURING PHACO AND IRRIGATION/ASPIRATION MODE OF SURGERY. THE SURGERY DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 21352965 ↗
• MalfunctionDec 3, 2024Break; Break

  A NURSE REPORTED THAT THE PHACOEMULSIFICATION (PHACO) TIP WAS BROKE OFF IN THE PATIENT'S EYE BUT REMAINED SECURELY WITHIN THE SLEEVE AND DID NOT COME LOOSE DURING THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE PHACO TIP WAS REMOVED DURING THE SAME SURGERY WITHOUT REQUIRING THE SURGEON TO REMOVE THE BROKEN PIECE DIRECTLY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PHACO TIP. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20829523 ↗
• MalfunctionNov 28, 2024Material Twisted/Bent; Material Twisted/Bent

  A NURSE REPORTED THAT TIP WAS BENT IN AN S-LIKE SHAPE INSIDE THE WRENCH DURING CALIBRATION. THE SURGERY WAS COMPLETED BY REPLACED WITH NEW PACK. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20804321 ↗
• MalfunctionNov 26, 2024Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT THE VACUUM STOPPED WORKING DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE CASSETTE WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785437 ↗
• MalfunctionNov 11, 2024Air/Gas in Device; Air/Gas in Device

  AN OPHTHALMOLOGIST REPORTED THE SURGEON HAS OBSERVED AIR BUBBLES RELEASED FROM THE PHACOEMULSIFICATION TIP DURING VARIOUS STAGES OF THE PHACOEMULSIFICATION PROCESS. WHILE THESE BUBBLES OBSCURE THE SURGEON'S VIEW AND REMOVED THROUGH ASPIRATION. THERE WAS NO PATIENT HARM. THIS IS TWO OF TWO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650073 ↗
• MalfunctionNov 11, 2024Air/Gas in Device; Air/Gas in Device

  AN OPHTHALMOLOGIST REPORTED THE SURGEON HAS OBSERVED AIR BUBBLES RELEASED FROM THE PHACOEMULSIFICATION TIP DURING VARIOUS STAGES OF THE PHACOEMULSIFICATION PROCESS. WHILE THESE BUBBLES OBSCURE THE SURGEON'S VIEW AND REMOVED THROUGH ASPIRATION. THERE WAS NO PATIENT HARM. THIS IS ONE OF TWO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650072 ↗
• MalfunctionNov 6, 2024Air/Gas in Device; Air/Gas in Device

  A CUSTOMER REPORTED THAT BUBBLES WERE ENTERING THE EYE DURING SURGERY. THE SURGERY WAS COMPLETED. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO SPECIFIC IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20618223 ↗
• MalfunctionOct 15, 2024Air/Gas in Device; Air/Gas in Device

  A CUSTOMER REPORTED THAT BUBBLES WERE ENTERING THE EYE THROUGH THE TUBING AND INTERFERING WITH VIEW OF SURGEON DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. ADDITIONAL INFORMATION REQUESTED AND RECEIVED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 20448945 ↗
• InjurySep 20, 2024Obstruction of Flow; Obstruction of Flow

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS CHAMBER INSTABILITY WITH AUDIBLE CASSETTE CLICKING SOUND DURING SURGERY. THE SURGEON RECENTLY BROKE CAPSULE BECAUSE OF TRAMPOLINING OF THE CHAMBER. THE PROCEDURE TYPE WAS UNKNOWN. IT WAS NOT KNOWN WHETHER THE SURGERY WAS COMPLETED. THERE WAS NO INFORMATION ABOUT CURRENT PATIENT CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Capsular Bag Tear; Intraocular Pressure Decreased

  MAUDE report 20268728 ↗
• MalfunctionSep 20, 2024Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT TIP WAS BENT INSIDE THE SYSTEM AT AN UNKNOWN TIMING. THE SURGERY TYPE AND COMPLETION WERE UNKNOWN. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20267063 ↗
• MalfunctionSep 11, 2024Break; Break

  THE NON-HEALTHCARE PROFESSIONAL REPORTED THAT PHACO NEEDLE SNAPPED IN HALF DURING A CASE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189992 ↗
• MalfunctionAug 5, 2024Complete Blockage; Complete Blockage

  A CUSTOMER REPORTED THAT THE TIP WAS OCCLUDED IN GOLD WRENCH WHILE SETTING UP THE PHACO HANDPIECE. TRIED TO FLUSH THE TIP TO RESOLVE BUT IT DID NOT WORK. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19905815 ↗
• MalfunctionJun 19, 2024Break; Break

  THE NON-HEALTHCARE PROFESSIONAL REPORTED THAT PHACO TIP HAD BROKEN DURING THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567626 ↗
• MalfunctionJun 11, 2024Material Twisted/Bent; Material Twisted/Bent

  THE NON HEALTH CARE PROFESSIONAL REPORTED THAT THE PHACO TIP IN THE FLUIDICS MANAGEMENT SYSTEM CASSETTE WAS BENT IN THE PACKAGING DURING SET UP. THE SECOND PHACO TIP WAS OPENED AND USED WITHOUT ISSUE AND WAS NOT KNOWN WHETHER THE PROCEDURE WAS COMPLETED ON THE SAME DAY OR NOT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19508044 ↗
• InjuryJun 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED THAT DURING CATARACT SURGERY IT WAS FOUND THAT THE PATIENT EXPERIENCED THERMAL INJURY FROM WHICH MILKY WHITE FLUID EMERGED. BY THE END OF THE PROCEDURE, THE WOUND GAPED, PRESENTING SIGNIFICANT DIFFICULTY IN CLOSURE, NECESSITATING THREE 10-0 NYLON SUTURES FOR CLOSURE. ADDITIONAL INFORMATION RECEIVED INDICATED EVENT OCCURRED DURING PHACOEMULSIFICATION MODE. THE PATIENT PRESENTED MILD CORNEAL OPACITY AND ASTIGMATISM. AN AMNIOTIC MEMBRANE WAS PLACED POST OPERATIVELY. FURTHER TREATMENT IS CURRENTLY NOT PLANNED.

  Patient problems: Eye Burn

  MAUDE report 19483655 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED INDICATED EVENT OCCURRED DURING PHACOEMULSIFICATION MODE. THE PATIENT PRESENTED MILD CORNEAL OPACITY AND ASTIGMATISM. AN AMNIOTIC MEMBRANE WAS PLACED POST OPERATIVELY. FURTHER TREATMENT IS CURRENTLY NOT PLANNED.

  Patient problems: Biliary Leak; Corneal Clouding/Hazing; Eye Burn; Fluid Discharge; Post Operative Wound Infection

  MAUDE report 19461993 ↗
• MalfunctionMay 9, 2024Material Twisted/Bent; Material Twisted/Bent

  THE NON-HEALTHCARE PROFESSIONAL REPORTED THAT PHACO TIP THAT ARRIVED WAS BENT. IT WAS UNKNOWN WHETHER THE SURGERY WAS COMPLETED OR NOT. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 19276541 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AFTER CATARACT SURGERY. THE CURRENT CONDITION OF THE PATIENT WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19201263 ↗
• MalfunctionJan 25, 2024Leak/Splash; Suction Failure; Leak/Splash; Suction Failure

  A NURSE REPORTED THAT LOST SUCTION DUE TO A LEAK OF CASSETTE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER PACK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18578458 ↗
• MalfunctionJan 17, 2024Material Separation; Material Separation

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT LOOSE TUBING AND CASSETTE WAS DEFECTIVE DURING SURGERY. THERE WAS NO REPORT OF SURGERY COMPLETION, PROCEDURE AND PATIENT HARM DETAILS.

  Patient problems: Insufficient Information

  MAUDE report 18526230 ↗
• MalfunctionOct 31, 2023Suction Problem; Defective Component; Suction Problem; Defective Component

  A CUSTOMER REPORTED THAT SEVERAL CASSETTES MALFUNCTIONED DURING THE CASES AND PHACO UNABLE TO PROVIDE VACUUM, CHANGED CASSETTE AND REPRIMED DURING CATARACT WITH INTRAOCULAR LENS IMPLANT SURGERY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18036468 ↗
• MalfunctionOct 25, 2023Suction Failure; Suction Failure

  THE NON HEALTHCARE PROFESSIONAL REPORTED THAT UNABLE TO PROVIDE VACUUM DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18002456 ↗
• MalfunctionSep 26, 2023Complete Blockage; Complete Blockage

  A CUSTOMER REPORTED THAT THE TIP WAS CLOGGED AT AN UNKNOWN TIMING. THE PROCEDURE WAS COMPLETED AFTER REPLACING IT WITH ANOTHER TIP. THERE WAS NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17817262 ↗
• MalfunctionSep 23, 2023Suction Failure; Suction Failure

  THE PHYSICIAN REPORTED THAT ASPIRATION WAS POOR DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED BY REPLACING A NEW PRODUCT. THE WAS NO REPORT OF PATIENT HARM.

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

  MAUDE report 17804939 ↗