BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON

    MDR report key: 5699205 · Received June 3, 2016

    Report

    Report Number
    2648035-2016-00860
    Event Type
    Injury
    Date Received
    June 3, 2016
    Report Date
    November 28, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS COULD NOT BE REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN/NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    UDI #: UNKNOWN SINCE SERIAL NUMBER WAS NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED CATALOG #, EXPIRATION DATE, AND SERIAL #: UNKNOWN, NOT PROVIDED. LENS WAS A +26.5 DIOPTER. IF IMPLANTED, GIVE DATE: UNKNOWN, NOT PROVIDED. IF EXPLANTED, GIVE DATE: DATE UNKNOWN BUT EXPLANT PERFORMED 9 YEARS AFTER IMPLANT. (B)(4). DEVICE MANUFACTURE DATE: UNKNOWN SINCE SERIAL NUMBER IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE ''BILATERAL RUPTURE OF THE POSTERIOR CAPSULE AND INTRAOCULAR LENS DISLOCATION FROM EXCESSIVE EYE RUBBING'' ARTICLE WAS REVIEWED. AUTHOR(S): RAMY BASSILY, BM, FRCOPHTH, ANNA LENCOVA, MD, PHD, FEBO, MADHAVAN S. RAJAN, MB BS, MS, MD, FRCOPHTH. PUBLICATION: J CATARACT REFRACT SURG 2016; 42:329¿331 CROWN COPYRIGHT Q 2016 PUBLISHED BY ELSEVIER INC. ON BEHALF OF ASCRS AND ESCRS. ALL RIGHTS RESERVED. HTTP://DX.DOI.ORG/10.1016/J.JCRS.2016.01.01. THE ARTICLE REPORTED AN UNUSUAL CASE OF A (B)(6)-YEAR-OLD WOMAN WITH SEVERE ATOPIC ECZEMA WHO DEVELOPED SUDDEN-ONSET REDUCTION OF VISION IN THE RIGHT EYE FOLLOWING EXCESSIVE EYE RUBBING 9 YEARS AFTER CATARACT SURGERY. EXAMINATION IDENTIFIED POSTERIOR CAPSULE RUPTURE WITH DISLOCATION OF THE INTRAOCULAR LENS (IOL) POSTERIORLY INTO THE VITREOUS CAVITY IN THE RIGHT EYE AND POSTERIOR CAPSULE RUPTURE WITH MILD DISLOCATION OF THE IOL IN THE BAG IN THE LEFT EYE. TO THE AUTHORS'' KNOWLEDGE, THIS WAS THE FIRST REPORTED CASE OF SIMULTANEOUS BILATERAL POSTERIOR CAPSULE RUPTURE FOLLOWING UNEVENTFUL SURGERY AND SECONDARY TO EYE RUBBING. SILICONE INTRAOCULAR LENSES, MODEL CEEON 911A, WERE IMPLANTED IN BOTH EYES: A +24.5 DIOPTER (D) LENS IN THE LEFT EYE AND A +26.5 D LENS IN THE RIGHT EYE. THE CAUSE OF THE CATARACTS WAS THOUGHT TO BE THE USE OF LONG-TERM SYSTEMIC STEROIDS TO CONTROL ATOPY AND SEVERE ECZEMA. THE PATIENT HAD NO HISTORY OF CONGENITAL CATARACTS, TRAUMA, OR CONNECTIVE TISSUE DISORDERS. THE ATOPY HAD REQUIRED LONG COURSES OF IMMUNOSUPPRESSION WITH STEROIDS, SYSTEMIC CYCLOSPORINE, AND AZATHIOPRINE THROUGHOUT HER LIFE. AT THE TIME OF PRESENTATION, THE PATIENT WAS TAKING A COURSE OF ORAL METHYLPREDNISOLONE FOR A FLARE-UP OF THE ECZEMA. THE PREVIOUSLY RECORDED CORRECTED PSEUDOPHAKIC VISUAL ACUITY WAS 6/6 SNELLEN IN BOTH EYES. SINCE BOTH EYES WERE AFFECTED, A SEPARATE MDR WILL BE FILED FOR EACH EYE. THIS MDR IS FOR THE RIGHT EYE WITH A 26.5 DIOPTER 911A LENS. ON PRESENTATION, THE CORRECTED DISTANCE VISUAL ACUITY (CDVA) IN THE RIGHT EYE WAS 6/36, IMPROVING TO 6/12 WITH PINHOLE. EXAMINATION OF THE POSTERIOR CHAMBER SHOWED A RUPTURED POSTERIOR CAPSULE WITH 1 LENS OPTIC EDGE DISLOCATED POSTERIOR TO THE CAPSULE. A SINGLE HAPTIC REMAINED IN THE CAPSULAR BAG, AND THE ANTERIOR HYALOID FACE WAS INTACT WITH NO VITREOUS PROLAPSE. THE LENS WAS EXPLANTED AND ANTERIOR VITRECTOMY WAS PERFORMED AND THE INCISION CLOSED WITH 10-0 NYLON SUTURES. THE FIRMLY ATTACHED HAPTIC FIBROSED INTO THE CAPSULAR BAG CAUSED ZONULAR DEHISCENCE DURING ITS REMOVAL, AND THE ANTERIOR CAPSULE WAS NOT SUFFICIENTLY STABLE TO ALLOW SULCUS PLACEMENT OF A LENS. A 19.5 DIOPTER IRIS-CLAW LENS (ANOTHER MANUFACTURER) WAS SUCCESSFULLY IMPLANTED, RESULTING IN A CDVA OF 6/6. ORAL CYCLOSPORINE-A WAS REINSTITUTED TO CONTROL THE ECZEMA, AND THE PATIENT WAS INSTRUCTED TO AVOID EYE RUBBING. SYSTEMIC THERAPY FOR ECZEMA RESULTED IN RESOLUTION OF THE OCULAR SURFACE SYMPTOMS AND INFLAMMATION RELATED TO ATOPY. THE MECHANISM OF THE POSTERIOR CAPSULE TEAR COULD HAVE BEEN FOCAL DIGITAL PRESSURE ON THE EYE THAT DISPLACED THE IOL VERTICALLY, CAUSING THE SHARP EDGE OF THE HAPTIC TO RUPTURE THE POSTERIOR CAPSULE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352961 CEEON MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS 911A

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention