BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF SINGLEPIECE IOL

    MDR report key: 15937435 · Received December 7, 2022

    Report

    Report Number
    1119421-2022-02605
    Event Type
    Injury
    Date Received
    December 7, 2022
    Report Date
    December 7, 2022
    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
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE LITERATURE REPORT DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. A MALFUNCTION HAS NOT BEEN INDICATED AGAINST THE PRODUCT. THE FILE HAS BEEN OPENED FROM A LITERATURE REPORT: VISUAL OUTCOMES AND COMPLICATIONS IN INFANTILE CATARACT SURGERY: A REAL - WORLD SCENARIO. THIS WAS A PROSPECTIVE OBSERVATIONAL STUDY EVALUATING INFANTS WITH CATARACT UNDERGOING SURGERY. PER INSTRUCTION FOR USE (IFU): COMPANY INTRAOCULAR LENSES (IOL) ARE INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG IN THE POSTERIOR CHAMBER OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED. THE USE IN INFANTS/CHILDREN IS OFF-LABEL USE OF THE PRODUCT. LITERATURE ARTICLE : CHATTANNAVAR G, BADAKERE A, MOHAMED A, KEKUNNAYA R. VISUAL OUTCOMES AND COMPLICATIONS IN INFANTILE CATARACT SURGERY: A REAL - WORLD SCENARIO. BMJ OPEN OPHTHALMOLOGY 2022;7:E000744. DOI:10.1136/BMJOPHTH-2021-000744. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED IN A JOURNAL ARTICLE THAT AFTER A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGICAL WOUNDS WERE SUTURED WITH NON-ABSORBABLE NYLON SUTURE. THE 54 IMPLANTED INFANTS WERE EXAMINED ON THE FIRST POSTOPERATIVE DAY AND UNDER GENERAL ANESTHESIA, AT THE BEGINNING OF THE FIRST WEEK, DURING WHICH SUTURES WERE REMOVED AND GLASSES OR CONTACT LENSES WERE PRESCRIBED. VISUAL AXIS OPACIFICATION HAS OCCURRED IN 12 OF THE INFANTS' EYES WITH IMPLANTED IOLS. NINE INFANTS WITH VISUAL AXIS OPACIFICATION UNDERWENT SECONDARY SURGERY FOR MEMBRANECTOMY. SECONDARY GLAUCOMA WAS DISCOVERED IN ONE OF THE INFANTS' IMPLANTED IOLS. IN ANOTHER ONE OF THE IMPLANTED IOL, AN INFANT EYE DEVELOPED ENDOPHTHALMITIS. THE INFANT WITH ENDOPHTHALMITIS RECEIVED INTRAVITREAL ANTIBIOTICS WITHOUT ANY DELAY AS TREATMENT FOR ENDOPHTHALMITIS. IN ANOTHER IMPLANTED IOL INFANT EYE, CORNEAL DECOMPENSATION WAS DIAGNOSED. IN ONE OF THE INFANTS, THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441287 ACRYSOF SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SA60AT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O