BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 9864962 · Received March 23, 2020

    Report

    Report Number
    1119421-2020-00486
    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: COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. (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 20/100 VISION SECONDARY TO 4+ PCO, AND A CAPSULOTOMY WAS PERFORMED. HER UCVA WAS 20/25 ON (B)(6) 2020. 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 REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332989 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SN60WF ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention