BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF MULTIPIECE IOL

    MDR report key: 22088197 · Received May 27, 2025

    Report

    Report Number
    1119421-2025-01514
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    April 28, 2025
    Report Date
    October 27, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652552530
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN D.9., H.3., H.6. AND H.11. THE LENS WAS RETURNED ANTERIOR SURFACE UP IN THE #79(IW) LENS CASE, POSITIONED INCORRECTLY. FIBERS WERE ADHERED ON THE LENS CASE AND ON BOTH SIDES OF THE LENS. THE LENS WAS CLEANED WITH KLRP FOR FURTHER EVALUATION. LONG AND SHORT, NARROW SCRATCHES WERE OBSERVED ON POSTERIOR SIDE OF THE LENS. NO HAPTIC DAMAGE WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW AND A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER WAS CONDUCTED. THE DEVIATION REVIEW DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. THE ACCOUNT INDICATED THE USE OF A QUALIFIED ASSOCIATED CARTRIDGE AND HANDPIECE WITH AN UNSPECIFIED VISCOELASTIC. IT IS UNKNOWN IF A QUALIFIED VISCOELASTIC WAS USED. THE REPORTED SCRATCH WAS OBSERVED. ONE LONG AND TWO SHORT ANGLED, NARROW SCRATCHES WERE OBSERVED POSTERIOR SURFACE OF THE OPTIC. THIS DAMAGE WAS SIMILAR TO DAMAGE CAUSED BY AN INSTRUMENT USED TO GRASP THE LENS. ALL LENSES ARE 100% INSPECTED FOR COSMETIC ATTRIBUTES AND THE DAMAGE EXHIBITED BY THE RETURNED COMPLAINT SAMPLE WOULD NOT HAVE MET COMPANY'S RELEASE CRITERIA. BASED ON OUR OBSERVATION, IT CAN BE REASONABLY CONCLUDED THAT THE DAMAGE IS NOT MANUFACTURING RELATED. DUE TO THE PRESENCE OF SURGICAL SOLUTION AND THE CONDITION OF THE RETURNED SAMPLE, THE DAMAGE IS MOST LIKELY RELATED TO CUSTOMER HANDLING. IT IS UNKNOWN IF A QUALIFIED VISCOELASTIC WAS USED. THE IFU (INSTRUCTIONS FOR USE) INSTRUCTS THAT AN COMPANY QUALIFIED DELIVERY SYSTEM AND VISCOELASTIC COMBINATION SHOULD BE USED. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO THE LENS AND POTENTIAL COMPLICATIONS DURING THE IMPLANTATION PROCESS. THE IFU INSTRUCTS TO COMPLETELY FILL THE CARTRIDGE WITH OVD (OPHTHALMIC VISCOSURGICAL DEVICE) IMMEDIATELY PRIOR TO LOADING AND DELIVERY OF THE LENS. DO NOT ATTEMPT TO LOAD THE LENS WITHOUT ADEQUATE OVD IN THE DEVICE. NOT ADEQUATELY FILLING THE DEVICE WITH VISCOELASTIC WILL RESULT IN INADEQUATE COVERAGE OF LENS AND THE LENS FOLD PATH WITH OVD, WHICH MAY RESULT IN DAMAGE. THE IFU INSTRUCTS: USE HOLDING FORCEPS TO GRASP THE LENS BY THE OPTIC EDGE AND GENTLY PLACE THE LENS ANTERIOR SIDE UP INTO THE BACK OF THE OVD-FILLED CARTRIDGE. THE LENS SHOULD BE INSERTED UNTIL IT IS CENTERED WITH OR SLIGHTLY PAST THE OUTLINE ETCHED INTO THE TOP OF THE CARTRIDGE. LENSES WITH A 6.5 MM OPTIC DIAMETER MAY NEED TO BE PRE-FOLDED FOR EASY ENTRY INTO THE BACK OF THE CARTRIDGE. LENS MAY BE PRE-FOLDED BY GENTLY APPLYING PRESSURE TO THE EDGE OF THE LENS WHILE HOLDING THE CENTRAL OPTIC WITH FORCEPS. THE TRAILING HAPTIC WILL EXTEND FROM THE PROXIMAL END OF THE CARTRIDGE. POSITION THE TRAILING HAPTIC TO THE LEFT OF THE HAPTIC POST AS SHOWN IN THE DETAILED VIEW. THIS WILL ALLOW THE PLUNGER TO GO PAST THE HAPTIC DURING THE INITIAL ADVANCEMENT OF THE PLUNGER INTO THE CARTRIDGE. VERIFY THE LENS IS POSITIONED ON THE BOTTOM SURFACE OF THE CARTRIDGE. THE HAPTIC SHOULD BE MAINTAINED TO THE LEFT OF THE POST WHEN THE LENS IS LOADED CORRECTLY. ACCURATE POSITIONING OF THE LENS WILL DECREASE THE POTENTIAL FOR OPTIC AND HAPTIC DAMAGE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE SURGEON ATTEMPTED TO LOAD THE IOL INTO THE CARTRIDGE AFTER REMOVING IT FROM THE PACKAGE, A SCRATCH WAS OBSERVED ON THE LENS. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH ANOTHER LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014623 ACRYSOF MULTIPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON MA60AC 15583243 00380652552530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B| MONARCH III IOL DELIVERY SYSTEM, INJECTOR