BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 12778982 · Received November 9, 2021

    Report

    Report Number
    3012712027-2021-00070
    Event Type
    Injury
    Date Received
    November 9, 2021
    Report Date
    November 8, 2021
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020210
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SITE REPORTED BILATERAL PATIENT HAD BOTH LIGHT ADJUSTABLE LENSES EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S AWARENESS DATE WAS 10/14/2021. THE DEVICE HISTORY RECORD FOR THE LENSES WERE REVIEWED. NO ISSUES WERE NOTED. SERIAL NUMBER: (B)(4), LOT NUMBER: L02-001446, MFG DATE: 12/4/2019, EXPIRATION DATE: 11/30/2022, UDI: (B)(4). SERIAL NUMBER: (B)(4), LOT NUMBER: L02-001525, MFG DATE: 1/4/2020, EXPIRATION DATE: 12/31/2022, UDI: (B)(4). THE EXPLANTED LENSES WERE RETURNED AND ARE CURRENTLY BEING EVALUATED.

    Additional Manufacturer Narrative · 0

    SITE REPORTED BILATERAL PATIENT HAD BOTH LIGHT ADJUSTABLE LENSES EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S AWARENESS DATE WAS 10/14/2021. THE EXPLANTED LENSES WERE RETURNED FOR EVALUATION. THE LENSES WERE CUT INTO MULTIPLE FRAGMENTS. VISUAL AND OPTICAL TESTING FOUND NO ISSUES WITH THE LENSES.

    Description of Event or Problem · 0

    SITE REPORTED BILATERAL PATIENT HAD BOTH LIGHT ADJUSTABLE LENSES EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S AWARENESS DATE WAS 10/14/2021.

    Description of Event or Problem · 0

    SITE REPORTED BILATERAL PATIENT HAD BOTH LIGHT ADJUSTABLE LENSES EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S AWARENESS DATE WAS 10/14/2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676269 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS PZK RXSIGHT, INC. 60005 L02-001446 00818806020210

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention