BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 9864891 · Received March 23, 2020

    Report

    Report Number
    1119421-2020-00485
    Event Type
    Injury
    Date Received
    March 23, 2020
    Report Date
    March 23, 2020
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SHE SEES A SPACE SHIP LIKE IMAGE, HER VISION IS BLURRY, BUT BETTER SINCE YAG LASER. ADDITIONAL INFORMATION WAS PROVIDED BY A PHYSICIAN THAT HE PERFORMED A YAG ON THIS PATIENT IN (B)(6). HER CATARACT SURGERIES WERE DONE BY A DIFFERENT PHYSICIAN IN 2012. THERE ARE NO DOCUMENTED VISUAL PROBLEMS OR DYSPHOTOPSIAS AT HER (B)(6) 2019 EXAM WITH A DIFFERENT DOCTOR (HER ONLY EXAM OF RECORD IN THE ELECTRONIC MEDICAL RECORD PRIOR TO THIS YEAR) AND SHE SAID SHE ONLY USED GLASSES FOR TINY PRINT. ON (B)(6) 2020, SHE HAD 20/60 VISION SECONDARY TO 3+ PCO AND A CAPSULOTOMY WAS PERFORMED. SHE WAS OFFERED A ONE WEEK FOLLOW UP IF SHE HAD ANY PROBLEMS OR NEEDED AN UPDATED PRESCRIPTION. SHE DID NOT RETURN AND HAS HAD NO DOCUMENTED CORRESPONDENCE WITH OUR OFFICE IN ELECTRONIC MEDICAL RECORDS. THERE ARE TWO MEDICAL DEVICE RECORDS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331963 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SN60WF 12098473

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention