BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTERIOR CHAMBER PMMA SINGLEPIECE IOL

    MDR report key: 16808112 · Received April 25, 2023

    Report

    Report Number
    1119421-2023-00771
    Event Type
    Injury
    Date Received
    April 25, 2023
    Date of Event
    November 29, 2022
    Report Date
    April 25, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652535861
    PMA / PMN Number
    P880087
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXPLANTED LENS WAS RETURNED INSIDE A PLASTIC SPECIMEN JAR. SOLUTION AND BLOOD WERE DRIED ON THE LENS. THE LENS WAS CLEANED WITH KLRP TO FURTHER ASSESS. ONE HAPTIC WAS CRACKED IN THE DISTAL AREA. THE CRACKED HAPTIC BROKE COMPLETELY DURING CLEANING. PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE CANNOT BE DETERMINED FOR THE REPORTED COMPLAINT OF "EXPLANT, LENS HAPTICS WERE PUSHING ON PERIPHERAL IRIS". THE REPORTED HAPTIC ISSUE COULD NOT BE CONFIRMED. IT IS NOT POSSIBLE TO CONFIRM IF HAPTICS WERE PUSHING ON IRIS. IT IS UNKNOWN IF PATIENT'S EYE ANATOMY CONTRIBUTED TO THE REPORTED COMPLAINT. THE EXPLANTED LENS HAD A CRACKED HAPTIC IN THE DISTAL AREA. THE HAPTIC FINISHED BREAKING DURING CLEANING. IT IS UNKNOWN IF THE CRACKED HAPTIC OCCURRED UPON IMPLANT OR EXPLANT. THE LENS WAS REPORTED IMPLANTED (B)(6) 2015. THE LENS WAS REMOVED (B)(6) 2023. THE COMPANY, 18.5 DIOPTER LENS WAS REPLACED WITH A NON-COMPANY THREE-PIECE LENS , 24.0 DIOPTER. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4 .

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAPTICS WERE PUSHING ON PERIPHERAL IRIS CAUSING INFLAMMATION. PATIENT EXPERIENCED NEVER BEING ABLE TO SEE WELL OUT OF LENS. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. DURING THE PROCEDURE PARS PLANA VITRECTOMY (PPV), AB-INTERNO CANALOPLASTY (ABIC), OMNI SURGICAL SYSTEM, GONIOTOMY, YAMANE AND LIMBAL RELAXING INCISIONS (LRI) WERE ALSO PERFORMED. THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT. PATIENT¿S SYMPTOMS WERE RESOLVED. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624739 ANTERIOR CHAMBER PMMA SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON MTA4U0 12382440 00380652535861

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention