BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF MULTIPIECE IOL

    MDR report key: 10097784 · Received May 28, 2020

    Report

    Report Number
    1119421-2020-00792
    Event Type
    Injury
    Date Received
    May 28, 2020
    Report Date
    May 25, 2020
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORT DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE DIRECTIONS FOR USE STATE THIS MODEL LENS IS INTENDED FOR PLACEMENT IN THE CAPSULAR BAG. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED IN A LITERATURE ARTICLE TITLED, CLINICAL OUTCOMES AND INTRAOCULAR PRESSURE (IOL) CONTROL AFTER SCLERAL-GLUED INTRAOCULAR LENS (IOL) INSERTION IN EYES WITH PSEUDOEXFOLIATION (PXF), THAT THE SCLERAL GLUED SURGERY IS A GOOD OPTION FOR FIXATING AN IOL IN EYES WITH PXF AND POOR ZONULAR INTEGRITY OR ABSENT CAPSULAR SUPPORT. SPECIAL ATTENTION SHOULD BE PLACED ON IOP CONTROL FOLLOWING SURGERY. THIS REPORT IS REGARDING ONE OF THREE EYES WHICH WERE COMPLICATED BY OPTIC CAPTURE, ALL OF WHICH INVOLVED ONE MODEL SCLERAL-GLUED IOL. THIS CASE DEVELOPED RECURRENT OPTIC CAPTURE THAT CAUSED IRIS CHAFING AND SIGNIFICANT VITREOUS HEMORRHAGE AT POSTOPERATIVE MONTH SIXTEEN; THIS EYE UNDERWENT A PARS PLANA VITRECTOMY AND IOL REPOSITIONING (USING THE SAME SCLERAL-GLUED TECHNIQUE) AT POSTOPERATIVE MONTH SEVENTEEN , FOLLOWED BY A SURGICAL PUPILLOPLASTY AT POSTOPERATIVE MONTH THIRTY-FOUR. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH OPTIC CAPTURE IN THIS ARTICLE. THIS REPORT IS ASSOCIATED WITH THE THIRD EYE WITH OPTIC CAPTURE REPORTED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560146 ACRYSOF MULTIPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON MA60AC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention