Alcon 8065752217Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00380657522170), received between Aug 28, 2023 and Dec 25, 2025 — classified as 3 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 25, 2025Obstruction of Flow; Obstruction of Flow

  A CUSTOMER REPORTED THAT CASSETTE MADE NOISE DURING SURGERY. THE PROCEDURE TYPE AND COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23892402 ↗
• MalfunctionOct 17, 2025Product Quality Problem; Product Quality Problem

  A PHYSICIAN REPORTED THAT THE SHAPE OF THE TIP OF A SLEEVE WAS FOUND DEFORMED AND LEAKAGE OCCURRED DURING CATARACT WITH INTRAOCULAR IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325372 ↗
• MalfunctionOct 15, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT TIP IN A PAK WAS FOUND BENT BEFORE THE CATARACT WITH INTRAOCULAR LENS IMPLANT 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 23279302 ↗
• MalfunctionSep 9, 2025Suction Problem; Suction Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PROBE COULD NOT ASPIRATE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23002786 ↗
• MalfunctionAug 22, 2025Leak/Splash; Suction Problem; Leak/Splash; Suction Problem

  A NURSE REPORTED THAT THERE WAS WATER LEAKAGE AT THE CONNECTION BETWEEN THE CASSETTE AND THE MACHINE, AND THE NEGATIVE PRESSURE COULD NOT BE INCREASED DURING CATARACT SURGERY (WITH INTRAOCULAR LENSES IMPLANT). 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 22877675 ↗
• InjuryMay 2, 2025Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow

  A PHYSICIAN REPORTED THAT THE EQUIPMENT PRESENTED OCCLUSION AND WAS NOT PERFORMING CATARACT ASPIRATION DURING CATARACT AND VITRECTOMY COMBINATION SURGERY IN THE LEFT EYE OF THE FEMALE ADULT PATIENT. THE PATIENT EXPERIENCED CORNEAL OPACITY ALONG WITH CORNEAL BURN BUT THERE WAS NO MEDICAL INTERVENTION. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE CASSETTE WITH ANOTHER ONE. ALTHOUGH THERE WAS PATIENT CONTACT WITH SUSPECT PRODUCT BUT THE PATIENT WAS RECOVERING WITH SEQUELAE. THIS REPORT PERTAINS TO THE CASSETTE INVOLVED IN THE REPORTED EVENTS.

  Patient problems: Corneal Clouding/Hazing; Eye Burn

  MAUDE report 21951498 ↗
• MalfunctionMay 1, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SCULPTING PHACOEMULSIFICATION (PHACO) TIP WAS BROKEN NEAR THE ASPIRATION BYPASS (AB) HOLE AND STUCK INSIDE THE SLEEVE DURING THE SURGERY CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED AFTER USING ANOTHER BALANCED ENERGY TIP. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941122 ↗
• MalfunctionApr 25, 2025Break; Break

  A PHYSICIAN REPORTED THAT BALANCED TIP WAS BROKEN INSIDE THE EYE DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911271 ↗
• MalfunctionApr 24, 2025Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT THE FLUID FLOW WAS OBSTRUCTED OR EVEN NO FLUID FLOW DURING THE CATARACT SURGERY WITHOUT INTRAOCULAR LENS IMPLANTATION. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899593 ↗
• MalfunctionMar 21, 2025Suction Problem; Suction Problem

  A HEALTH CARE PROFESSIONAL REPORTED PAK WAS DEFECTIVE BECAUSE THERE WAS NO SUCTION DURING (AT THE START) OF CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS COMPLETED WITH ANOTHER PAK. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661222 ↗
• InjuryFeb 18, 2025Break; Break

  A PHYSICIAN REPORTED TIP WAS BROKEN INSIDE THE PATIENT¿S EYE AND SUFFERED WOUND BURN WHICH RESULTED IN MILD SCARRING WITH ASTIGMATISM DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT AND REMOVED THE BROKEN PARTS THEN DOCTOR ASKED TO OPEN A NEW CASSETTE WITH A NEW TIP. PROCEDURE COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO PATIENT IMPACT.

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

  MAUDE report 21398050 ↗
• MalfunctionJan 31, 2025Break; Break

  A PHYSICIAN REPORTED THAT THE PHACOEMULSIFICATION (PHACO) TIP WAS BROKEN DURING THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED BY REPLACING THE CASSETTE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280997 ↗
• MalfunctionJan 8, 2025Break; Break

  A PHYSICIAN REPORTED THAT TIP WAS BROKEN DURING CATARACT SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21108694 ↗
• MalfunctionNov 22, 2024Suction Problem; Suction Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT ASPIRATION AND ULTRASOUND DELIVERY WAS DEFECT DURING SURGERY. PROCEDURE TYPE AND COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO REPORT OF PATIENT IMPACT. ADDITIONAL INFORMATION WAS PROVIDED THAT, SURGERY WAS COMPLETED BY REPLACED WITH NEW CASSETTE DURING CATARACT SURGERY. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20760798 ↗
• MalfunctionOct 28, 2024Accessory Incompatible; Inability to Irrigate; Accessory Incompatible; Inability to Irrigate

  A PHARMACIST REPORTED THAT NO INFUSION WITH THE PACK AND BALL INSIDE THE DRIP CHAMBER WAS STUCK DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20542994 ↗
• MalfunctionOct 28, 2024Accessory Incompatible; Inability to Irrigate; Accessory Incompatible; Inability to Irrigate

  A PHARMACIST REPORTED THAT NO INFUSION WITH THE PACK AND BALL INSIDE THE DRIP CHAMBER WAS STUCK DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20542993 ↗
• MalfunctionOct 18, 2024Complete Blockage; Suction Problem; Complete Blockage; Suction Problem

  A NURSE REPORTED THAT THE CASSETTE WAS BLOCKED AND THE SUCTION WAS INSUFFICIENT DURING CATARACT SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE CASSETTE WITH NEW ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20479285 ↗
• MalfunctionOct 15, 2024Complete Blockage; Infusion or Flow Problem; Complete Blockage; Infusion or Flow Problem

  A PHARMACIST REPORTED THAT THAT THE BALL INSIDE THE DRIP CHAMBER WAS STUCK AND THERE WAS NO INFUSION DURING CATARACT SURGERY WITH INTRA OCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PACK WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20448938 ↗
• MalfunctionOct 8, 2024Inability to Irrigate; Inability to Irrigate

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE SERUM FLOW FROM THE CASSETTE WAS DEFECTIVE BECAUSE IT DID NOT FILTER THE AIR INTO THE BALANCED SALT SOLUTION AND IT CAUSED A SLIGHT COLLAPSE OF THE ANTERIOR CHAMBER DURING PHACOEMULSIFICATION WITH INTRAOCULAR LENS IMPLANT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE CASSETTE WITH ANOTHER ONE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 20394665 ↗
• MalfunctionSep 25, 2024Material Twisted/Bent; Packaging Problem; Material Twisted/Bent; Packaging Problem

  A CUSTOMER REPORTED THAT THE DUE TO THE OMISSION OF THE OUTER PACKAGING FOR THE TUBES, INFUSION TUBE WAS KINKED WHICH LED TO A FLOW STOP DURING INTRAOCULAR LENS IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO INFORMATION OF PATIENT HARM IN HE COMPLAINT. ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO PATIENT IMPAIRMENT, SINCE THE FLOW ONLY STOPPED FOR A SHORT TIME. IF THAT HAD NOT BEEN THE CASE NARROWING IN THE HOSE THAT WOULD NOT HAD SOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304585 ↗
• MalfunctionSep 20, 2024Break; Break

  THE CUSTOMER REPORTED THAT TIP OF THE NEEDLE WAS BROKEN DURING CATARACT SURGERY WITHOUT INTRAOCULAR IMPLANT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING WITH ANOTHER TIP. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20264922 ↗
• InjuryJul 10, 2024Infusion or Flow Problem; Infusion or Flow Problem

  A NURSE REPORTED THAT THE ERROR CODE DISPLAYED RESULTING IN SUDDEN ANTERIOR CHAMBER COLLAPSE AND THE INFUSION VOLUME WAS VERY SLOW OR EVEN DID NOT PRODUCE WATER, WHICH CANNOT REACH THE REQUIRED INFUSION PRESSURE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACEMENT OF NEW PRODUCT. THE PATIENT HAD NO ADVERSE REACTIONS AFTER SURGERY.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 19708485 ↗
• MalfunctionMay 7, 2024Suction Failure; Suction Failure

  THE PHYSICIAN REPORTED THAT ASPIRATION PRESSURE DID NOT INCREASE WHILE USING ULTRA SOUND MODE DURING THE SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER PACK. THERE WAS NO PATIENT HARM. THE PROCEDURE TYPE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257678 ↗
• MalfunctionApr 29, 2024Break; Break

  A PHYSICIAN REPORTED THAT BALANCED TIP BROKEN DURING SURGERY. THE PROCEDURE DETAILS AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION RECEIVED THAT THE SURGERY WAS COMPLETED AFTER REPLACING THE TIP WITH ANOTHER TIP. THE PROCEDURE TYPE WAS CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201373 ↗
• MalfunctionApr 24, 2024Break; Break

  A PHYSICIAN REPORTED THAT BALANCED TIP GOT BROKEN DURING SURGERY. THE PROCEDURE DETAILS AND PATIENT HARM WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19173336 ↗