BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSTERIOR CHAMBER LENS

    MDR report key: 2070132 · Received April 22, 2011

    Report

    Report Number
    1119421-2011-00468
    Event Type
    Injury
    Date Received
    April 22, 2011
    Report Date
    March 23, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P840060
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE, THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ROOT CAUSE: NO SERIAL/LOT NUMBER OR SAMPLE WAS PROVIDED BY THE CUSTOMER. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. ADDITIONAL INFO HAS BEEN REQUESTED. MORENO J, SALINAS A, BARRIO J, BONET E. PUPIL CAPTURE OF INTRAOCULAR LENS IN VITRECTOMIZED EYE WITH PRIMARY PIGMENT DISPERSION SYNDROME. J CATARACT REFRACT SURG. 2011 MAR; 37(3):612-613. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 04/22/2011. (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE, IT WAS REPORTED THAT A PARS PLANA VITRECTOMY WAS PERFORMED IN THE RIGHT EYE OF A (B)(6) YEAR-OLD MAN WITH A RETINAL DETACHMENT AND PREVIOUS CATARACT SURGERY AND A NORMAL LEFT EYE. FOUR YEARS LATER, THE INTRAOCULAR LENS (IOL) -CAPSULAR BAG COMPLEX WAS DISLOCATED; THE IOL-CAPSULAR BAG WAS REMOVED, AND IOL WAS SUTURED TRANSSCLERALLY AT THE 3 AND 9 O'CLOCK POSITIONS. THIS IOL IS SINGLE-PIECE IOL THAT IS COMMONLY USED FOR SCLERAL FIXATION. THE EYELETS IN THE HAPTICS ALLOW STABLE FIXATION, AND THE LARGE OPTIC FACILITATES CENTRATION. TWO MONTHS LATER, THE PT RETURNED WITH TEMPORAL ENTRAPMENT OF THE OPTIC IOL BY THE PUPIL. THERE WERE NO CHANGES IN THE INTRAOCULAR PRESSURE (IOP) OR VISUAL ACUITY AND NO PSEUDOPHAKODONESIS OR IOL TILTING. THE PUPILLARY CAPTURE WAS TREATED WITH MEDICATION AND A FACE-UP POSITION FOR 15 MINS. THE DISTANCE BETWEEN THE CORNEA AND IOL WAS 5.21 MM. ONE WEEK LATER, IOL ENTRAPMENT RECURRED. GONIOSCOPY SHOWED BACKWARD BOWING OF THE IRIS BILATERALLY AND TRABECULAR MESHWORK PIGMENTATION. IRIS TRANSILLUMINATION SHOWED SPOKE-LIKE PATTERN DEFECTS IN THE MID-PERIPHERAL IRIS. NO KRUKENBERG SPINDLE PIGMENTATION WAS FOUND. THE IOP WAS 16 MM HG BILATERALLY. LASER PERIPHERAL IRIDOTOMY WAS PERFORMED IN THE RIGHT EYE, AND ONE YEAR LATER, THE IRIS WAS FLAT WITH NO IOL RECAPTURE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSTERIOR CHAMBER LENS INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON CZ70BD NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention