BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR

    MDR report key: 2922832 · Received January 18, 2013

    Report

    Report Number
    2648035-2013-00019
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    January 4, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Removal / Correction Number
    2648035-01-03-13-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT A SECOND, ADDITIONAL SURGERY. THE SURGERY WAS PERFORMED (B)(6) 2013. ANOTHER INTRAOCULAR LENS, (IOL) WAS IMPLANTED AS A PIGGY BACK LENS. NO FURTHER INFORMATION WAS PROVIDED. MEDICATION: ELTROXIN, CONVERSUM, PHYSIOTENS, DIAMICRON METFORMIN-MEPHA, ACTOS, IRFEN, PANPRAX EYE DROPS. 7 WEEKS POST-OP REFRECTION IS + 3,75 - 0,5/60. ACTUAL TAKING FOLLOWING MEDICATION: TOBRADEX UND NEVANAC EYE DROPS. MEDICAL HISTORY PRE-OP DIAGNOSIS: CATARACTA SENILIS OS (LEFT EYE). BEST CORRECTED VISUAL ACUITY (BCVA): 0.6. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    SECONDARY SURGICAL PROCEDURE IS SCHEDULED FOR (B)(4), 2013. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT IS BEING CORRECTED TO 2-JAN-2013. DATE RECEIVED BY MANUFACTURER IS BEING CORRECTED TO 2-JAN-2013. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH, IS BEING CORRECTED TO (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE PRIMARY CAUSE FOR THIS EVENT WAS THE INADVERTENT SWITCHING OF THE DEVICE HISTORY RECORD (DHR)/LABELING POUCHES BETWEEN THE TWO TOTES OF IMPACTED LENSES ON AN IN-PROCESS STORAGE RACK. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) WHICH IS PART OF A PRODUCT RECALL. ABBOTT ISSUED THE PRODUCT RECALL DUE A DIOPTER MIX-UP BETWEEN TWO LOTS. IN ADDITION, IT WAS STATED THAT THE SURGEON PERFORMED A SECONDARY PROCEDURE TO PIGGYBACK AN ADDITIONAL LENS DUE TO UNEXPECTED POST OPERATIVE REFRACTION. NO ADDITIONAL INFORMATION REGARDING PATIENT STATUS WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27662 SENSAR MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention