Alcon 00380650001337Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00380650001337), received between Nov 21, 2022 and Jul 29, 2025 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Break; Break

  A CUSTOMER REPORTED THAT PHACOEMULSIFICATION TIP WAS BROKE DURING SURGERY. PATIENT IMPACT AND PROCEDURE DETAILS WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22640351 ↗
• MalfunctionNov 4, 2024Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED BY REPLACING THE NEW CASSETTE PACK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20596475 ↗
• MalfunctionOct 30, 2024Complete Blockage; Complete Blockage

  THE NON-HEALTHCARE PROFESSIONAL REPORTED THAT HANDPIECES BEING BLOCKED OR CLOGGED AT AN UNKNOWN TIMING. ONCE FLUIDIC MANAGEMENT SYSTEM WAS CHANGED THE ISSUE WAS RESOLVED. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20565233 ↗
• MalfunctionOct 24, 2024Obstruction of Flow; Suction Failure; Obstruction of Flow; Suction Failure

  THE NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT (PHACOEMULSIFICATION MODE) THE ASPIRATION WAS LOW AND THE SYSTEM OCCLUSION WAS HEARD WITH NO OCCLUSION OR SYSTEM MESSAGE GIVEN. IT WAS ATTEMPTED THE REFLUX SETTING AND INCREASED ASPIRATION WHICH DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED BY OPENING A NEW CASSETTE PAK. THERE WAS PATIENT CONTACT WITH NO IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520603 ↗
• MalfunctionOct 16, 2024Break; Break

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT THE PHACO TIP WAS BROKEN DURING CATARACT SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE TIP WITH NEW ONE. THERE WAS NO INFORMATION ABOUT PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 20459747 ↗
• MalfunctionSep 26, 2024Material Twisted/Bent; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT WHILE TIGHTENING THE TIP ONTO THE HANDPIECE WITH THE PLASTIC WRENCH PROVIDED THAT THE PHACOEMULSIFICATION TIP WAS BENT DURING CALIBRATION OF CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT (IOL)). THE SURGERY WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20308855 ↗
• MalfunctionSep 26, 2024Material Twisted/Bent; Material Twisted/Bent

  A CUSTOMER REPORTED THAT THE PHACOEMULSIFICATION TIP WAS BENT DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PHACOEMULSIFICATION TIP WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20308431 ↗
• MalfunctionSep 26, 2024Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT PHACOEMULSIFICATION (PHACO) TIP BROKE IN PATIENT EYE. ADDITIONAL INFORMATION REQUESTED AND RECEIVED THAT THE IRRIGATION SUDDENLY DECREASED IN PHACO MODE, THEN THE TIP WAS REMOVED FROM THE PATIENT¿S EYE AND DISCOVERED THAT THE PHACO TIP WAS BROKEN IN HALF JUST ABOVE THE HUB AND CONTAINED IN THE SLEEVE. THE EVENT OCCURRED DURING THE SCULPT MODE OF CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE NEW PHACO TIP. PATIENT WAS CONTACTED WITH PRODUCT BUT THERE WAS NO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 20308241 ↗
• MalfunctionAug 6, 2024Break; Break

  A PHYSICIAN REPORTED THAT PHACOEMULSIFICATION TIP WAS BROKEN DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT .THE SURGERY WAS COMPLETED BY REPLACING WITH NEW ONE. THERE WAS NO PATIENT HARM.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 19919157 ↗
• MalfunctionAug 2, 2024Break; Break

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT A PHACO TIP WAS FOUND TO BE BROKEN DURING SURGERY. THE BROKEN TIP WAS NOTICED WHILE STILL IN THE SLEEVE AND ALTHOUGH IT WAS IN THE EYE IT WAS REMOVED. THE PROCEDURE TYPE WAS UNKNOWN. THE TIP WAS REPLACED AND THE CASE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19892431 ↗
• MalfunctionJul 17, 2024Break; Break

  A CUSTOMER REPORTED PHACOEMULSIFICATION TIP BROKE IN HALF DURING PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NEW PHACOEMULSIFICATION TIP AND SLEEVE. THERE WAS A PATIENT CONTACT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19758381 ↗
• MalfunctionJul 16, 2024Material Twisted/Bent; Material Twisted/Bent

  A NONHEALTHCARE PROFESSIONAL REPORTED THAT THE PHACOEMULSIFICATION TIP WAS BENT BEFORE CATARACT SURGERY (WITH (IOL) INTRAOCULAR LENS IMPLANT). THE SURGERY WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19747708 ↗
• InjuryJul 2, 2024Complete Blockage; Complete Blockage

  A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, THE PHACOEMULSIFICATION HANDPIECE AND BALANCE TIP FAILED TO IRRIGATE, CAUSING AN ERROR MESSAGE AND RESULTING IN A WOUND BURN IN THE PATIENT'S RIGHT EYE. THE WOUND WAS SUTURED, AND THE SURGEON HAS ALSO CONFIRMED HEARING OCCLUSION BELLS. ON POST-OPERATIVE DAY 3, AN EYE EXAMINATION REVEALED CORNEAL EDEMA AND MINIMAL INDUCED ASTIGMATISM DUE TO THE SUTURING AND WOUND BURN. THE PATIENT'S CONDITION IS IMPROVING.

  Patient problems: Eye Burn

  MAUDE report 19657254 ↗
• MalfunctionMay 22, 2024Break; Break

  A CUSTOMER REPORTED THAT THE BALANCED TIP WAS BROKEN INSIDE A PATIENT'S EYE AND ALL PIECES WERE REMOVED DURING SCULPT MODE OF THE CATARACT EXTRACTION WITH INTRAOCULAR LENSES IMPLANT PROCEDURE. THE FRAGMENT WAS NEVER LOOSE INSIDE THE EYE AND IT STAYED INSIDE THE IRRIGATION SLEEVE. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371604 ↗
• MalfunctionMar 5, 2024Complete Blockage; Complete Blockage

  A HEALTHCARE PROFESSIONAL REPORTED THAT TUBING CONSISTENTLY BEING CLOGGED DURING PHACO. NO INFORMATION WAS PROVIDED ON COMPLETION OF SURGERY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838879 ↗
• MalfunctionMar 5, 2024Complete Blockage; Complete Blockage

  A HEALTHCARE PROFESSIONAL REPORTED THAT TUBING CONSISTENTLY BEING CLOGGED DURING PHACO. NO INFORMATION WAS PROVIDED ON COMPLETION OF SURGERY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838664 ↗
• MalfunctionFeb 29, 2024Obstruction of Flow; Suction Failure; Obstruction of Flow; Suction Failure

  A PHYSICIAN REPORTED THAT NO ASPIRATION, CASSETTE WITH THE PRESUMED BLOCKAGE AND SUTURE WAS USED TO CLOSE WOUND AS A PRECAUTION. THE SURGERY WAS COMPLETED AFTER REPLACING WITH CASSETTE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED FROM PHYSICIAN THAT NO ASPIRATION, CASSETTE WITH THE PRESUMED BLOCKAGE AND SUTURE WAS USED TO CLOSE WOUND AS A PRECAUTION DURING CATARACT SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18805618 ↗
• MalfunctionNov 9, 2023Inability to Irrigate; Inability to Irrigate

  A NON-HEALTHCARE PROFESSION REPORTED ERROR CODE WAS DISPLAYED AND IRRIGATION RANDOMLY TURNING OFF OR NOT CONSISTENTLY PROVIDED PRESSURE AS NORMAL DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM.

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

  MAUDE report 18101042 ↗
• MalfunctionAug 28, 2023Dent in Material; Dent in Material

  A HEALTHCARE PROFESSIONAL REPORTED PHACO TIP APPEARED JAGGED DURING THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED WITH REPLACING ANOTHER PHACO TIP. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17631666 ↗
• MalfunctionMay 23, 2023Break; Break

  A CUSTOMER REPORTED THAT THE PHACO TIP HAD BROKEN WHILE IN THE PATIENT¿S EYE DURING CATARACT SURGERY (WITH INTRAOCULAR LENSES IMPLANT). THIS EVENT WAS OCCURRED ON (B)(6) 2023 WHILE USING PHACO, THE SURGEON FELT LIKE SOMETHING WAS A LITTLE OFF AND REMOVED THE PHACO HANDPIECE. THERE WAS NO PATIENT HARM. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16982959 ↗
• MalfunctionJan 13, 2023Particulates; Particulates

  A NURSE REPORTED 2MMX1MM, OVAL CURLED LOOKING LIKE A PIECE OF PLASTIC, FLOATING FREELY IN ANTERIOR CHAMBER DURING PHACOEMULSIFICATION PHASE OF A CATARACT SURGERY. THERE WAS NO REPORT OF A PATIENT HARM. THIS IS SECOND OF THE TWO REPORTS. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE WHO INDICATED THERE WAS NO HARM TO THE PATIENT. PATIENT HAD NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16155869 ↗
• MalfunctionJan 12, 2023Particulates; Particulates

  A NURSE REPORTED SMALL TRANSLUCENT PIECE (2MMX1MM, OVAL CURLED), LOOKING LIKE A PIECE OF PLASTIC, FLOATING FREELY IN ANTERIOR CHAMBER DURING PHACOEMULSIFICATION PHASE OF A CATARACT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER NONE HAS BEEN RECEIVED TILL DATE. THIS IS ONE OF THE TWO REPORTS. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE WHO INDICATED THERE WAS NO HARM TO THE PATIENT. PATIENT HAD NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16154967 ↗
• MalfunctionNov 21, 2022Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED A PHACOEMULSIFICATION (PHACO) TIP BROKE OFF IN THE PATIENTS LEFT EYE INTRAOPERATIVELY DURING THE PHACO PHASE OF THE CATARACT PROCEDURE. THE BROKEN TIP WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NEW PHACO TIP. THERE WAS NO PATIENT HARM. THE SAMPLE WAS NOT AVAILABLE FOR A RETURN. ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPANY REPRESENTATIVE INDICATING THAT SHORTLY AFTER BEGINNING THE PHACOEMULSIFICATION ON A DENSE LENS, THE PHACO NEEDLE TIP WAS NOTED TO HAVE BROKEN OFF THE PHACO NEEDLE (A 6MM PIECE OF NEEDLE WAS LEFT EMBEDDED IN THE LENS NUCLEUS, COMPLETELY SEVERED FROM THE PHACO HANDPIECE). THE BROKEN NEEDLE FRAGMENT WAS REMOVED AND A NEW PHACO NEEDLE WAS INSTALLED AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833598 ↗