BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LEN

    MDR report key: 594824 · Received November 2, 2001

    Report

    Report Number
    2023826-2004-01771
    Event Type
    Injury
    Date Received
    November 2, 2001
    Date of Event
    October 22, 2001
    Report Date
    November 2, 2001
    Manufacturer
    *
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A CC4204BF COLLAMER LENS. THE PATIENT HAD A POST-OP EXAM IN 10/2001 AND THEIR EYE WAS DOING OKAY. IN 10/2001 THE PATIENT RETURNED WITH A INTRAOCULAR INFECTION, ENDOPHTHALMITIS. THE PATIENT'S PRE-OP INTRAOCULAR PRESSURE WAS 18, POST-OP IS 23. TREATMENT INCLUDED VITREOUS TAP, INTRAOCULAR INJECTION AND TOPICAL DROPS. PATIENT'S PRE-OP VISUAL ACUITY WAS 20/200. PATIENT'S POST-OP UNCORRECTED VISUAL ACUITY IS 20/HM (HAND MOTION) CULTURES HAD BEEN PERFORMED AND THE RESULT WAS COAG NEGATIVE STAPH EPI. DIAGNOSIS: ENDOPHTHALMITIS. THE IOL INJECTION, MODEL AND LOT # UNKNOWN. THE IOL INJECTION CARTRIDGE, MODEL AND LOT # UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49749 UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LEN INTRAOCULAR LENS HQL * CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R