BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 11902523 · Received May 28, 2021

    Report

    Report Number
    3012712027-2021-00022
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 28, 2021
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020166
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE REPORTED THAT A PATIENT HAD BEEN IMPLANTED WITH A LIGHT ADJUSTABLE LENS, BUT DID NOT RETURN FOR ANY FOLLOW-UP LIGHT TREATMENTS. THE PATIENT ALSO DID NOT COMPLY WITH UV PROTECTIVE EYEWEAR. THE PATIENT RETURNED APPROXIMATELY 6 MONTHS AFTER CATARACT SURGERY WITH COMPLAINTS OF BLURRY VISION. PREMATURE PHOTOPOLYMERIZATION OF THE LENS WAS CONFIRMED. THE LENS WAS EXPLANTED ON (B)(6) 2021. DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED. NO ISSUES WERE NOTED. THE LENS WAS NOT SAVED AFTER EXPLANT. THE SITE DISCARDED THE LENS.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT A PATIENT HAD BEEN IMPLANTED WITH A LIGHT ADJUSTABLE LENS, BUT DID NOT RETURN FOR ANY FOLLOW-UP LIGHT TREATMENTS. THE PATIENT ALSO DID NOT COMPLY WITH UV PROTECTIVE EYEWEAR. THE PATIENT RETURNED APPROXIMATELY 6 MONTHS AFTER CATARACT SURGERY WITH COMPLAINTS OF BLURRY VISION. PREMATURE PHOTOPOLYMERIZATION OF THE LENS WAS CONFIRMED. THE LENS WAS EXPLANTED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800239 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL0 PZK RXSIGHT, INC. 60005 L02-001201 00818806020166

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention