BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 12234771 · Received July 27, 2021

    Report

    Report Number
    3012712027-2021-00035
    Event Type
    Injury
    Date Received
    July 27, 2021
    Date of Event
    June 29, 2021
    Report Date
    July 27, 2021
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020197
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SITE REPORTED BILATERAL PATIENT UNDERWENT LAL IMPLANTATION IN (B)(6) 2021 ((B)(6) 2021 FOR THE LEFT EYE AND (B)(6) 2021 FOR THE RIGHT EYE). THE LALS WERE EXPLANTED IN (B)(6) 2021 ((B)(6) 2021 FOR THE RIGHT EYE, (B)(6) 2021 FOR THE LEFT EYE). RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 7/1/2021. THE EXPLANTED LENSES WERE VISUALLY INSPECTED AND OPTICALLY TESTED. BOTH LENSES WERE FOUND TO HAVE AN AMBIENT ZONE, WHICH IS INDICATIVE OF THE LENSES BEING EXPOSED TO AMBIENT UV LIGHT PRIOR TO LOCK IN.

    Description of Event or Problem · 0

    SITE REPORTED BILATERAL PATIENT UNDERWENT LAL IMPLANTATION IN (B)(6) 2021 ((B)(6)2021 FOR THE LEFT EYE AND (B)(6) 2021 FOR THE RIGHT EYE). THE LALS WERE EXPLANTED IN (B)(6) 2021 (6/28/2021 FOR THE RIGHT EYE, (B)(6) 2021 FOR THE LEFT EYE). RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 7/1/2021.

    Additional Manufacturer Narrative · 1

    SITE REPORTED BILATERAL PATIENT UNDERWENT LAL IMPLANTATION IN (B)(6) 2021 ( (B)(6) 2021 FOR THE LEFT EYE AND (B)(6) 2021 FOR THE RIGHT EYE). THE LALS WERE EXPLANTED IN (B)(6) 2021 ( (B)(6) 2021 FOR THE RIGHT EYE, (B)(6) 2021 FOR THE LEFT EYE). RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2021. THE DEVICE HISTORY RECORDS FOR BOTH OF THE LENSES WERE REVIEWED. NO ISSUES WERE NOTED. RIGHT EYE: SERIAL NUMBER: (B)(4), LOT NUMBER: L02-001960, IMPLANT DATE: (B)(6) 2021, MFG DATE: 12/10/2020, EXPIRATION DATE:11/30/2023, EXPLANT DATE: (B)(6) 2021, UDI: (B)(4) . LEFT EYE: SERIAL NUMBER: (B)(4) , LOT NUMBER: L02-001755, IMPLANT DATE: (B)(6) 2021, MFG DATE: 7/26/2020, EXPIRATION DATE: 6/30/2023, EXPLANT DATE: (B)(6) 2021, UDI: (B)(4). THE LENSES HAVE BEEN RECEIVED AND ARE CURRENTLY BEING EVALUATED.

    Description of Event or Problem · 1

    SITE REPORTED BILATERAL PATIENT UNDERWENT LAL IMPLANTATION IN (B)(6) 2021 ( (B)(6) 2021 FOR THE LEFT EYE AND (B)(6) 2021 FOR THE RIGHT EYE). THE LALS WERE EXPLANTED IN (B)(6) 2021 ((B)(6)2021 FOR THE RIGHT EYE, (B)(6) 2021 FOR THE LEFT EYE). RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132112 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L02-001960 00818806020197

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention