BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL)

    MDR report key: 10857310 · Received November 17, 2020

    Report

    Report Number
    3012712027-2020-00036
    Event Type
    Injury
    Date Received
    November 17, 2020
    Date of Event
    October 27, 2020
    Report Date
    November 17, 2020
    Manufacturer
    RXSIGHT, INC.
    Product Code
    HQL
    UDI-DI
    00818806020289
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT PRESENTED FOR LDD TREATMENT WITH IRITIS. THE DOCTOR ALSO NOTED IRIS ADHESION, PREVENTING COMPLETE DILATION. THE PHYSICIAN SURGICALLY BROKE THE IRIS ADHESION TO RESOLVE THE ISSUE. DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED. NO ISSUES WERE NOTED. THE SURGEON DID NOTE THAT HE SUSPECTED THE PATIENT DISCONTINUED THE POST OPERATIVE DROP REGIMEN EARLY. THE LENS REMAINS IMPLANTED WITHIN THE PATIENT'S EYE. NO PRODUCT WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    PATIENT PRESENTED FOR LDD TREATMENT WITH IRITIS. THE DOCTOR ALSO NOTED IRIS ADHESION, PREVENTING COMPLETE DILATION. THE PHYSICIAN SURGICALLY BROKE THE IRIS ADHESION TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321173 RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL) INTRAOCULAR LENS HQL RXSIGHT, INC. 60005 L02-001507 00818806020289

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention