BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 8593784 · Received May 8, 2019

    Report

    Report Number
    1119421-2019-00628
    Event Type
    Injury
    Date Received
    May 8, 2019
    Date of Event
    March 14, 2019
    Report Date
    May 8, 2019
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A HEALTH AGENCY REPORTED THAT FOLLOWING A COMBINED PHACOEMULSIFICATION AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS GIVEN LOCAL AND SYSTEMIC ANTI-INFLAMMATORY DRUGS AS SYMPTOMATIC TREATMENT. TWO DAYS FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AND THE SLIT LAMP EXAMINATION FINDINGS WERE CONJUNCTIVAL HYPERAEMIA, CORNEAL EDEMA, ANTERIOR CHAMBER FLASHING, POSTERIOR IRIS ADHESION, CENTRAL PUPIL, D=3MM, VISIBLE DIRECT LIGHT RESPONSE, FILAMENTOUS FLOATING MATTER ON THE SURFACE OF LENS, DIAGNOSTIC REJECTION REACTION. THE PATIENT WAS TREATED WITH PUPIL DILATATION AND SUBCONJUNCTIVAL INJECTION OF ANTI-INFLAMMATORY DRUGS, AND GRADUALLY IMPROVED ON THE FOURTH POSTOPERATIVE DAY. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386833 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SN60WF ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention