BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 11739588 · Received April 28, 2021

    Report

    Report Number
    3012712027-2021-00019
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    April 13, 2021
    Report Date
    April 28, 2021
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020173
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN REPORTED DURING DELIVERY OF THE LAL, THE SURGEON FELT THE LENS EXITED THE CARTRIDGE QUICKLY, CAUSING A TEAR IN THE BAG AT THE EQUATOR. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITHOUT ADDITIONAL ISSUE. THE DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED. NO ISSUES WERE NOTED. THE LENS REMAINS IMPLANTED IN THE PATIENT'S EYE.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED DURING DELIVERY OF THE LAL, THE SURGEON FELT THE LENS EXITED THE CARTRIDGE QUICKLY, CAUSING A TEAR IN THE BAG AT THE EQUATOR. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITHOUT ADDITIONAL ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637586 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL0 PZK RXSIGHT, INC. 60005 L02-001833 00818806020173

    Patients

    Seq Age Sex Outcome Treatment
    1 Other