BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF SINGLEPIECE IOL

    MDR report key: 19861109 · Received July 30, 2024

    Report

    Report Number
    1119421-2024-01441
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    July 1, 2024
    Report Date
    November 4, 2024
    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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION- CHATTANNAVAR G ET AL., VISUAL OUTCOMES AND SAFETY PROFILE OF INTRAOCULAR LENS IMPLANTATION VERSUS APHAKIA IN CHILDREN WITH MICROSPHEROPHAKIA WITH NO SUBLUXATION. BMJ OPEN OPHTHALMOLOGY. 2023;8:E001049. NO SAMPLE WAS AVAILABLE TO RETURN. 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. THE ROOT CAUSE COULD NOT BE DETERMINED. THE FILE HAS BEEN OPENED FROM A LITERATURE REPORT: VISUAL OUTCOMES AND SAFETY PROFILE OF INTRAOCULAR LENS IMPLANTATION VERSUS APHAKIA IN CHILDREN WITH MICROSPHEROPHAKIA WITH NO SUBLUXATION. IN THE BAG IOL IS AN OPTION, WHICH CAN BE CONSIDERED IN SELECTED CASES OF MICROSPHEROPHAKIA IN DEVELOPING NATIONS WHERE REGULAR FOLLOW-UP AND ECONOMIC CONSTRAINTS ARE A MAJOR CONCERN. PER THE IFU: LENS POSTERIOR CHAMBER INTRAOCULAR LENSES ARE INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS FOLLOWING CATARACT SURGERY WHEN EXTRACAPSULAR CATARACT EXTRACTION OR PHACOEMULSIFICATION ARE PERFORMED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED VIA LITERATURE ARTICLE TO STUDY THE VISUAL, REFRACTIVE AND SURGICAL OUTCOMES OF INTRAOCULAR LENS (IOL) IMPLANTATION VERSUS APHAKIA IN CHILDREN WITH MICROSPHEROPHAKIA. THIS IS A RETROSPECTIVE, COMPARATIVE, NON-RANDOMIZED INTERVENTIONAL STUDY. THEY RETROSPECTIVELY REVIEWED THE ELECTRONIC MEDICAL RECORDS OF CHILDREN DIAGNOSED WITH MICROSPHEROPHAKIA WITHOUT SUBLUXATION AND UNDERWENT SURGERY AT INSTITUTE, DURING THE PERIOD FROM MAY 2017 TO MARCH 2021 WITH A MINIMUM FOLLOW-UP OF 6 WEEKS POST SURGERY. ONLY CHILDREN WITH CLINICALLY DIAGNOSED MICROSPHEROPHAKIA WITH CLEAR LENS AND NO SUBLUXATION AND NORMAL INTRAOCULAR PRESSURE (IOP) WITH NO SIGN OF GLAUCOMA WERE INCLUDED IN THE STUDY. CHILDREN WITH SUBLUXATED LENS, CATARACT, RAISED IOP AND OPTIC DISC SHOWING GLAUCOMATOUS CHANGES WERE EXCLUDED FROM THE STUDY. ONLY CHILDREN WHOSE PARENTS WHO AGREED FOR IOL IMPLANTATION IN-THE-BAG WERE INCLUDED AS CASES (GROUP A) AND REST OF THE CHILDREN WHO WERE LEFT APHAKIC IN THE CONTROL GROUP (GROUP B). THIS CASE IS ABOUT TWO PATIENTS INTRAOPERATIVELY, TWO EYES IN GROUP A (16.6%) HAD DEVELOPED PUPILLARY BLOCK AND IRIS PROLAPSE THROUGH THE SIDE PORT AFTER IOL IMPLANTATION IN THE BAG, WHICH SETTLED AFTER A PERIPHERAL SURGICAL IRIDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188444 ACRYSOF SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SA60AT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R WAVELIGHT OB820