BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2464380 · Received February 22, 2012

    Report

    Report Number
    9614546-2012-00029
    Event Type
    Injury
    Date Received
    February 22, 2012
    Date of Event
    January 4, 2012
    Report Date
    January 23, 2012
    Manufacturer
    AMO GRONINGEN B.V.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN E-MAIL WAS RECEIVED FROM THE REPORTING PHYSICIAN, (B)(6), STATING THAT THE DIAGNOSIS OF THE MALIGNANT GLAUCOMA WAS CONFIRMED. AFTER TREATMENTS WITH ATROPINE, DIAMOX, PHENYLEFRINE AND B-BLOCKERS THE LENS MOVED BACKWARDS, PRESSURE NORMALIZED, AND THE UNEXPECTED MYOPIA DISAPPEARED. SO HAPPILY THERE WAS A GOOD POSTOP RESULT AND THERE WAS NO CORRELATION WITH THE TECNIS MULTIFOCAL LENS ITSELF. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS (AMO) HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED. PRIOR TO RELEASE TO MARKET THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO DEVIATIONS.ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED IMPLANTING A ZMB00 27.5 DIOPTER MULTIFOCAL INTRAOCULAR LENS INTO A FEMALE PATIENT. HEALON AND HEALON 5 WERE USED DURING SURGERY AND BALANCED SALT SOLUTION FOR IRRIGATION. THE PATIENT HAD A NARROW ANTERIOR CHAMBER AND AN OPEN IRIDOTOMY. AT ONE DAY POST-OP THE PATIENT WAS -3.5D MYOPIC. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. TOPOGRAPHY IS NORMAL. PREOPERATIVE VISUAL ACUITY WAS 20/25 [=0.8]. POST-OP VISUAL ACUITY WAS 20/20 [= 1.0] WITH -3.0D MYOPIA. AT ONE DAY POST IMPLANTATION, TOBRADEX 3X/D AND DICLOABAK 3X/D WERE GIVEN, BUT BECAUSE OF PRESSURE RISE AFTER ONE WEEK, GELTIM 1X/D AND TRAFLOXAL EDO 4X/D WERE GIVEN INSTEAD. AT 7 DAY POST-OP, THE PRESSURE OF THE EYE WAS 36MM HG BUT BECAME NORMAL AFTER ANTIGLAUCOMA DROPS (21MM HG) HOWEVER, THE MYOPIA DID NOT CHANGE AFTER NORMALIZATION OF THE PRESSURE. AT 10 DAY POST-OP THERE WAS NO CHANGE. EVERYTHING SEEMED TO BE NORMAL WITH EXCEPTION OF THE -3.5D MYOPIA. IN ADDITION, THE SURGEON REPORTED THAT HE PERFORMED A PRE-OP IRIDOTOMY WITH YAG WITHOUT ANY PROBLEMS AND NO SHALLOWING OF THE ANTERIOR CHAMBER. A CAPSULAR TENSION RING (CTR) WAS ALSO IMPLANTED. THE DISTANCE BETWEEN THE ENDOTHELIUM AND IOL WAS MEASURED BY PENTACAM PRINT-OUT. THE DIMENSION MEASURED IS 2680'M. THE IOL REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK AMO GRONINGEN B.V. ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention