BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL0

    MDR report key: 11784987 · Received May 6, 2021

    Report

    Report Number
    3012712027-2021-00020
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    April 6, 2021
    Report Date
    May 6, 2021
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020159
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SITE REPORTED THAT PATIENT WAS INITIALLY IMPLANTED WITH THE LIGHT ADJUSTABLE LENS AND HAD A GOOD OUTCOME. THE PATIENT THEN REPORTED CLOUDY VISION. RETROILLUMINATION OF THE EYE VERIFIED PREMATURE PHOTOPOLYMERIZATION OF THE LENS. THE LENS WAS EXPLANTED ON (B)(6) 2021. THE EXPLANTED LENS WAS RETURNED FOR EVALUATION. INSPECTION OF THE RETURNED LENS CONFIRMED THE PRESENCE OF A ZONE IN THE CENTER OF THE LENS, WHICH IS INDICATIVE OF PREMATURE PHOTOPOLYMERIZATION OF THE LENS.

    Description of Event or Problem · 0

    SITE REPORTED THAT PATIENT WAS INITIALLY IMPLANTED WITH THE LIGHT ADJUSTABLE LENS AND HAD A GOOD OUTCOME. THE PATIENT THEN REPORTED CLOUDY VISION. RETROILLUMINATION OF THE EYE VERIFIED PREMATURE PHOTOPOLYMERIZATION OF THE LENS. THE LENS WAS EXPLANTED ON (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    SITE REPORTED THAT PATIENT WAS INITIALLY IMPLANTED WITH THE LIGHT ADJUSTABLE LENS AND HAD A GOOD OUTCOME. THE PATIENT THEN REPORTED CLOUDY VISION. RETROILLUMINATION OF THE EYE VERIFIED PREMATURE PHOTOPOLYMERIZATION OF THE LENS. THE LENS WAS EXPLANTED ON (B)(6) 2021. DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED. NO ISSUES WERE NOTED. THE EXPLANTED LENS HAS BEEN RETURNED AND IS CURRENTLY BEING EVALUATED.

    Description of Event or Problem · 1

    SITE REPORTED THAT PATIENT WAS INITIALLY IMPLANTED WITH THE LIGHT ADJUSTABLE LENS AND HAD A GOOD OUTCOME. THE PATIENT THEN REPORTED CLOUDY VISION. RETROILLUMINATION OF THE EYE VERIFIED PREMATURE PHOTOPOLYMERIZATION OF THE LENS. THE LENS WAS EXPLANTED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680500 LIGHT ADJUSTABLE LENS (LAL0 LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L02-001349 00818806020159

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention