Alcon 8065752192Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380657521920), received between Jul 13, 2022 and Apr 28, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Obstruction of Flow; Suction Failure; Obstruction of Flow; Suction Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC OPERATING SYSTEM EXHIBITED WITH NO VACUUM BUILD UP AND INDICATING OCCLUSION DURING QUADRANT PHASE OF IOL IMPLANTATION SURGERY. SURGERY WAS COMPLETED AFTER REPLACING CASSETTE AND HANDPIECE. PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 21916240 ↗
• MalfunctionMar 19, 2025Material Twisted/Bent; Material Twisted/Bent

  A CUSTOMER REPORTED A FLUIDICS MANAGEMENT SYSTEM (FMS) PACK RECEIVED WITH A DAMAGED PHACOEMULSIFICATION TIP. THE PHACOEMULSIFICATION TIP WAS NOTED TO BE CURVED IN AN UNUSUAL WAY PRIOR TO PATIENT CONTACT DURING CALIBRATION OF CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS COMPLETED WITH ANOTHER FLUIDICS MANAGEMENT SYSTEM (FMS) PAK. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642856 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT THE CARTRIDGE OR BAG WAS LEAKING ONTO THE FLOOR. THE CARTRIDGE WAS REPOSITIONED, WHICH APPARENTLY INTRODUCED AIR INTO THE LINE, RESULTING IN SUDDEN AIR FILL OF THE ANTERIOR CHAMBER AND POSTERIOR CAPSULAR RUPTURE DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY.

  Patient problems: Rupture

  MAUDE report 17902479 ↗
• MalfunctionAug 9, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT THE PHACO TIPS DID NOT THREAD CORRECTLY ONTO THE HANDPIECE BEFORE CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17485724 ↗
• MalfunctionJan 12, 2023Suction Failure; Suction Failure

  AN OPHTHALMOLOGIST REPORTED THAT VACUUM STOPPED WORKING DURING THE EARLY QUADRANT REMOVAL. THE SURGEON STOPPED THE HANDPIECE (HP) AND FLUSHED ALSO TRIED VACUUMING WATER FROM A BOWL, BUT THE PROBLEM PERSISTED. THEREFORE, THE HP WAS CHANGED. THE VACUUM STILL PERSISTED; THEREFORE, THE CARTRIDGE (FMS) WAS CHANGED AND REPRIMED. FOLLOWING THIS, AN ERROR CODE WAS DISPLAYED AND HP WAS NO LONGER COULD BE PRIMED. THE HP WAS CHANGED FOR A THIRD TIME, BUT PROBLEM PERSISTED. A FULL RESET AND ALL THE EQUIPMENT WERE CHANGED; HOWEVER, VACUUM STILL REMAINED REDUCED FOR THE REMAINDER OF THE SURGERY. THE SURGEON FINISHED THE SURGERY WITHOUT ANY TROUBLE. HOWEVER, THE PATIENT HAD RETAINED THE LENS FRAGMENTS WHICH WERE LATER REMOVED IN A SURGERY PERFORMED LATER ON A DIFFERENT DAY. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16146433 ↗
• MalfunctionSep 12, 2022Suction Failure; Suction Failure

  A CUSTOMER REPORTED THERE WAS NO VACUUM FLOW AND STOPPED WORKING DURING THE CATARACT PROCEDURE. ALL SETTING AND SYSTEMS APPEARED TO BE WORKING FINE. THE FLUIDICS MANAGEMENT SYSTEM (FMS) PAK WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE INDICATED THERE WAS NO ISSUE WITH THE IRRIGATION (FLUID GOING IN) BUT ONLY HAD NO ASPIRATION/FLOW OR VACUUM (FLUID COMING OUT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15400987 ↗
• MalfunctionAug 5, 2022Signal Artifact/Noise; Defective Device; Suction Failure; Signal Artifact/Noise; Defective Device; Suction Failure

  A CUSTOMER REPORTED A CASSETTE MALFUNCTION WHICH LED TO TEMPORAL WOUND BURN, THE HANDPIECE WAS UNABLE TO ASPIRATE UPON INITIATING THE PHACOEMULSIFICATION (PHACO) AND DELIVERY ULTRASOUND ENERGY DURING THE CATARACT PROCEDURE. WHITENING OF VISCOELASTIC WAS ALSO NOTED WITH OCCLUSION SOUNDING ON PHACO WHICH IMMEDIATELY CEASED. THE TEMPORAL WOUND BURN WAS NOTED AND COPIOUS IRRIGATION WITH BALANCE SALT SOLUTION (BSS) APPLIED. THE CASSETTE WAS REPLACED WITH A NEW ONE AND ONCE AGAIN PRIMED WITH THE SAME HANDPIECE AND NOW THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING WOUND BURN AS CORNEAL BURN.

  Patient problems: Eye Burn

  MAUDE report 15174069 ↗
• InjuryJul 13, 2022Device Alarm System; Inability to Irrigate; Device Alarm System; Inability to Irrigate

  A CUSTOMER REPORTED INADEQUATE FLUID WAS IRRIGATING THE EYE AND THE PATIENT SUFFERED A WOUND BURN. THE PROCEDURE WAS COMPLETED AFTER THE PRODUCT WAS REPLACED. THE PATIENT REQUIRED SUTURING OF THE WOUND. THE SAMPLE IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE WHO INDICATED OCCLUSION TONE WAS HEARD DURING THE PROCEDURE. THE CORNEAL BURN RESULTED IN MILD GAPING AT END OF PROCEDURE BUT NO LEAK WAS OBSERVED WITH WOUND HYDRATION. THE PATIENT WAS SUTURED WITH ONE NYLON 10/0 FOR SAFETY. THE INJURY RESULTED IN POSTOPERATIVE ASTIGMATISM WHICH VALUED TO BE D1 6/12 (UNAIDED) AND FURTHER REVIEW FOR ASSESSING ASTIGMATISM WAS PLANNED IN A WEEK. THE BURN RESULTED IN CORNEAL OPACITY WHICH WAS CLEARED SIGNIFICANTLY AFTER THE EPITHELIUM WAS CLEARED OFF. THE PATIENT WAS STABLE ON DAY-1 POST OPERATION. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE WHO INDICATED THE PATIENT'S CURRENT CONDITION IS IMPROVING.

  Patient problems: Corneal Edema; Eye Burn

  MAUDE report 14999483 ↗