BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 11703872 · Received April 21, 2021

    Report

    Report Number
    3012712027-2021-00018
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 21, 2021
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020210
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT REPORTED A DECREASE IN VISION IN THE LEFT EYE FOLLOWING AN EVENING OUTDOORS WITHOUT UV SPECTACLE WEAR. PATIENT HAD NOT YET BEEN LOCKED IN. DOCTOR SUSPECTS PREMATURE PHOTOPOLYMERIZATION OF THE LENS. THE LENS WAS REMOVED ON (B)(6) 2021 AND REPLACED WITH ANOTHER LIGHT ADJUSTABLE LENS. VISUAL INSPECTION OF THE RETURNED LENS FOUND THE LENS HAD BEEN CUT INTO MULTIPLE FRAGMENTS. VISUAL INSPECTION AND OPTICAL TESTING COULD NOT CONFIRM THE PRESENCE OF A ZONE ON THE LENS DUE TO THE EXTENSIVE DAMAGE TO THE LENS.

    Description of Event or Problem · 0

    PATIENT REPORTED A DECREASE IN VISION IN THE LEFT EYE FOLLOWING AN EVENING OUTDOORS WITHOUT UV SPECTACLE WEAR. PATIENT HAD NOT YET BEEN LOCKED IN. DOCTOR SUSPECTS PREMATURE PHOTOPOLYMERIZATION OF THE LENS. THE LENS WAS REMOVED ON (B)(6) 2021 AND REPLACED WITH ANOTHER LIGHT ADJUSTABLE LENS.

    Additional Manufacturer Narrative · 1

    PATIENT REPORTED A DECREASE IN VISION IN THE LEFT EYE FOLLOWING AN EVENING OUTDOORS WITHOUT UV SPECTACLE WEAR. PATIENT HAD NOT YET BEEN LOCKED IN. DOCTOR SUSPECTS PREMATURE PHOTOPOLYMERIZATION OF THE LENS. THE LENS WAS REMOVED ON (B)(6) 2021 AND REPLACED WITH ANOTHER LIGHT ADJUSTABLE LENS. DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED. NO ISSUES WERE NOTED. THE EXPLANTED LENS HAS BEEN RETURNED AND IS BEING EVALUATED.

    Description of Event or Problem · 1

    PATIENT REPORTED A DECREASE IN VISION IN THE LEFT EYE FOLLOWING AN EVENING OUTDOORS WITHOUT UV SPECTACLE WEAR. PATIENT HAD NOT YET BEEN LOCKED IN. DOCTOR SUSPECTS PREMATURE PHOTOPOLYMERIZATION OF THE LENS. THE LENS WAS REMOVED ON (B)(6) 2021 AND REPLACED WITH ANOTHER LIGHT ADJUSTABLE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598489 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L02-001765 00818806020210

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention