BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 14176279 · Received April 21, 2022

    Report

    Report Number
    3012712027-2022-00016
    Event Type
    Injury
    Date Received
    April 21, 2022
    Report Date
    April 21, 2022
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020685
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM A PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AS TO THE REASON FOR THE EXPLANT. RXSIGHT'S FIRST AWARENESS WAS 3/25/2022. DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED. NO ISSUES WERE NOTED. THE EXPLANTED LENS WAS RETURNED FOR EVALUATION. THE LENS WAS CUT INTO MULTIPLE FRAGMENTS. VISUAL AND OPTICAL TESTING OF THE LENS FOUND NO ISSUE WITH THE LENS.

    Additional Manufacturer Narrative · 0

    SITE REPORTED BILATERAL PATIENT HAD LIGHT ADJUSTABLE LENSES EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED AS TO THE REASON FOR THE EXPLANT. RXSIGHT'S FIRST AWARENESS WAS 3/25/2022. DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED. NO ISSUES WERE NOTED. SERIAL NUMBER: (B)(6). LOT NUMBER: L07-003235. MFG DATE: 5/23/2021. EXPIRATION DATE: 4/30/2024. UDI: (B)(4). SERIAL NUMBER: (B)(6). LOT NUMBER: L07-003368. MFG DATE: 8/10/2021. EXPIRATION DATE: 7/31/2024. UDI: (B)(6). BOTH EXPLANTED LENSES WERE RETURNED FOR EVALUATION. VISUAL INSPECTION AND OPTICAL TESTING OF THE RETURNED LENSES FOUND NO ISSUES WITH THE LENSES.

    Description of Event or Problem · 0

    THE SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM A PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AS TO THE REASON FOR THE EXPLANT. RXSIGHT'S FIRST AWARENESS WAS 3/25/2022.

    Description of Event or Problem · 0

    SITE REPORTED BILATERAL PATIENT HAD LIGHT ADJUSTABLE LENSES EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED AS TO THE REASON FOR THE EXPLANT. RXSIGHT'S FIRST AWARENESS WAS 3/25/2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627111 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L07-003235 00818806020685

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other