BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK --- IOL

    MDR report key: 3093659 · Received May 1, 2013

    Report

    Report Number
    1119421-2013-00468
    Event Type
    Injury
    Date Received
    May 1, 2013
    Report Date
    April 4, 2013
    Manufacturer
    ALCON RESEARCH. LTD / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. HONG Y, SUN YX, HONG C, ZHOU JC, HAO Y. PIGMENT DISPERSION GLAUCOMA INDUCED BY THE CHAFING EFFECT OF INTRAOCULAR LENS HAPTICS IN ASIAN EYES. CURRENT EYE RESEARCH, 2013, 38(3): 358-62. (B)(4).

    Description of Event or Problem · 1

    THE AUTHORS OF A JOURNAL ARTICLE REPORT THE FINDINGS OF PIGMENT DISPERSION GLAUCOMA (PDG) INDUCED BY THE CHAFING EFFECT OF SINGLE PIECE ACRYLIC (SPA) INTRAOCULAR LENSES (IOLS) IN ASIAN EYES. THE AUTHORS REPORTED THE RESULTS OF A RETROSPECTIVE STUDY OF PTS REFERRED TO THEIR HOSPITAL BETWEEN (B)(6) 2005 TO (B)(6) 2011. THE PURPOSE OF THIS STUDY WAS TO EXAMINE THE POSSIBLE MECHANISMS OF AND TREATMENT FOR PDG CAUSED BY SPA IOL CILIARY SULCUS FIXATION IN ASIAN EYES. A TOTAL OF SIX EYES FROM FIVE PTS WERE STUDIED. A SLIT LAMP EXAMINATION SHOWED THAT THE IOLS WERE COMPLETELY OR PARTIALLY OUTSIDE THE CAPSULAR BAG. POSTERIOR CAPSULE RUPTURE AND BROKEN LENS ZONULES WERE OBSERVED IN THREE EYES AND TWO EYES, RESPECTIVELY. PIGMENTATION DEPOSITS ON THE OPTICAL PART OF THE IOL WERE NOTED IN ALL PTS. A TYPICAL SLIT-LAMP PHOTOGRAPH OF A PT'S EYE SHOWED THE UPPER IOL HAPTIC WAS IN THE CILIARY SULCUS, AND IRIS TRANSILLUMINATION DEFECTS WAS NOTED IN THE UPPER HAPTIC REGION. OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED THAT THE IOL WAS ANTERIOR TO THE CAPSULAR BAG, AN THE HAPTIC WAS IN CONTACT WITH THE REAR IRIS SURFACE, WHICH MAY HAVE CAUSED IRIS CHAFING. THE IOLS WERE REPOSITIONED IN THREE EYES BECAUSE THE CAPSULAR BAG COULD BE REOPENED IN THESE EYES, AND THE IOL WAS REPOSITIONED IN THE BAG. A COMBINED TRABECULECTOMY WAS PERFORMED IN TWO EYES WITH PROGRESSIVE VISUAL FIELD DEFECTS. THE CAPSULAR BAG OF THE OTHER THREE EYES WAS DIFFICULT TO REOPEN; THEREFORE, AN IOL EXCHANGE WAS PERFORMED USING A THREE PIECE IOL WITH CILIARY SULCUS FIXATION. ALL THE PTS HAD SIMULTANEOUS ANTERIOR VITRECTOMY. THE IOP WAS CONTROLLED WITHOUT VISUAL FIELD DEFECT PROGRESSION. IN THE REPORTED STUDY, THE AUTHORS FOUND THAT ALL PTS ENROLLED HAD SECONDARY GLAUCOMA WITHIN A MONTH AFTER CATARACT SURGERY. THE AUTHORS HYPOTHESIZE THAT THIS COULD BE DUE TO THE HIGHER PIGMENTATION IN ASIAN PTS COMPARED TO CAUCASIAN PTS. WHEN CHAFING OCCURS, THERE ARE MORE EXFOLIATED IRIS PIGMENTS, THE SYMPTOMS ARE MORE SEVERE, AND THE TRABECULAR MESHWORK IS MORE EASILY OBSTRUCTED. OTHER POSSIBLE REASON MAY INCLUDE THICKER IRIS AND SHORTER AXIAL LENGTH OF ASIAN EYES WHICH MAKES THE ASIAN EYES MORE PRONE TO HAVE CHAFING OF IRIS PIGMENT EPITHELIALIUM WITH SPL IOL HAPTICS. THESE ANATOMICAL DIFFERENCE MAY INDUCE MORE SEVERE PDG THAT REQUIRES SURGICAL INTERVENTION. THIS REPORT IS FOR THE SECOND PT. THIS PT HAD AN IOL EXCHANGE DUE TO A PRESUMED POSTERIOR CAPSULER TEAR. THERE ARE SIX MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE SECOND PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189421 UNK --- IOL INTRAOCULAR LENS HQL ALCON RESEARCH. LTD / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention