BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROVIEW INTRAOCCULAR LENS

    MDR report key: 431487 · Received December 5, 2002

    Report

    Report Number
    1920664-2002-00384
    Event Type
    Injury
    Date Received
    December 5, 2002
    Date of Event
    August 9, 2002
    Report Date
    November 7, 2002
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE LENS OPACIFICATION WAS OBSERVED ON 08/09/2002. DATE OF ORIGINAL SURGERY: 2001. THE PATIENT PREOPERATIVE VISUAL ACUITY WAS 20/1000, POST-OP IT WAS 20/100. AT THE LAST EXAMINATION IN 10/2002 THE PATIENT VISUAL EXAMINATION HAD DECREASED TO 20/200. THE LENS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROVIEW INTRAOCCULAR LENS INTRAOCULAR LENS HQL BAUSCH & LOMB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other