BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON ASPHERIC UV ABSORBING IOL

    MDR report key: 21631170 · Received March 18, 2025

    Report

    Report Number
    1119421-2025-00724
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    February 18, 2025
    Report Date
    May 2, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652396868
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    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 PROVIDED IN D.9. , H.3. , H.6. AND H.11. THE LENS WAS RETURNED FOR EVALUATION. SOLUTION IS DRIED ON THE LENS. ONE HAPTIC IS BROKEN IN THE GUSSET AREA (NOT RETURNED). THE OPPOSITE HAPTIC IS BENT IN THE GUSSET AREA CAUSING THE HAPTIC TO POINT DOWN IN THE LENS CASE. A POST IS BROKEN IN THE LENS CASE NEXT TO THE GUSSET AREA OF THE BENT HAPTIC. DAMAGE IS OBSERVED TO THE GUSSET AREA WITH A DEEP SCRAPE MARK ON THE ANTERIOR SURFACE. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ASSOCIATED PRODUCTS WERE NOT PROVIDED. IT IS UNKNOWN IF QUALIFIED PRODUCTS WERE USED. BROKEN HAPTIC DAMAGE WAS OBSERVED. THE FILE INDICATES THE DAMAGE WAS OBSERVED WHEN LOADING THE LENS. ALL LENSES ARE 100 PERCENT INSPECTED FOR COSMETIC ATTRIBUTES AND THE DAMAGE EXHIBITED BY THE RETURNED COMPLAINT SAMPLE WOULD NOT HAVE MET COMPANY 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. ASSOCIATED PRODUCTS WERE NOT PROVIDED. IT IS UNKNOWN IF QUALIFIED PRODUCTS WERE USED. COMPANY FOLDABLE IOLS ARE QUALIFIED FOR USE WITH AN COMPANY QUALIFIED DELIVERY SYSTEM (HANDPIECE AND CARTRIDGE) AND OPHTHALMIC VISCOSURGICAL DEVICE (OVD) COMBINATION. 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: USING HOLDING FORCEPS, 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 THE OPTIC IS A LITTLE MORE THAN HALF-WAY INSIDE THE CARTRIDGE. USE THE HOLDING FORCEPS TO GENTLY PUSH DOWN ON THE LENS, VERIFYING THAT THE LENS IS ON THE BOTTOM SURFACE OF THE CARTRIDGE. USING HOLDING FORCEPS, TAKE THE TRAILING HAPTIC, AND GENTLY FOLD THE HAPTIC ONTO THE ANTERIOR SIDE OF THE OPTIC. SLOWLY GRIP OR PUSH THE OPTIC EDGE TO POSITION THE LENS AS FAR INTO THE CARTRIDGE AS THE FORCEPS WILL PERMIT, WHILE ENSURING THE LENS REMAINS ON THE BOTTOM SURFACE OF THE CARTRIDGE AND THE TRAILING HAPTIC REMAINS ON THE OPTIC. FAILURE TO FOLLOW THESE STEPS MAY CAUSE THE LENS TO ADVANCE INCORRECTLY CAUSING DELIVERY ISSUES AND/OR DAMAGE. COMPANY IFU: FOLLOW THE SECTION REGARDING DIRECTIONS FOR USE FOR INFORMATION ON THE MAXIMUM ALLOWED TIME FOR THE IOL TO STAY IN THE FOLDED CONDITION. FAILURE TO ADHERE TO MANUFACTURER RECOMMENDATIONS MAY RESULT IN IOL DAMAGE. IFU NOTE: DURING LENS LOADING AND INSERTION, DO NOT ALLOW THE COMPANY IOL TO REMAIN IN A FOLDED CONDITION WITHIN THE SELECTED IOL DELIVERY SYSTEM FOR MORE THAN 3 MINUTES PRIOR TO COMPLETING INSERTION INTO THE CAPSULAR BAG. DUE DILIGENCE HAS BEEN PERFORMED IN AN ATTEMPT TO OBTAIN FURTHER INFORMATION ON THIS EVENT. THE REPORTER HAS NOT RESPONDED TO REQUEST FOR FOLLOW-UP INFORMATION. FILE WILL BE REOPENED IF NEW INFORMATION OR THE SAMPLE IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON LOADING THE LENS NOTICED THE HAPTIC WAS MISSING. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804463 CLAREON ASPHERIC UV ABSORBING IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON CC60WF 15891476 00380652396868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown