BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS

    MDR report key: 1940383 · Received December 20, 2010

    Report

    Report Number
    1119279-2010-00136
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    August 31, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ACCORDING TO THE SURGEON, THE PATIENT MAY HAVE HAD WEAK ZONULES PRIOR TO THE CATARACT REMOVAL THAT WENT UNDETECTED. A DHR REVIEW HAS BEEN REQUESTED AND RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS A PATIENT THAT IS DISSATISFIED WITH HER VISUAL OUTCOME AFTER UNDERGOING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF AN AO60G INTRAOCULAR LENS. THE PATIENT'S PREOPERATIVE UNCORRECTED VISUAL ACUITY WAS 20/50. DURING INSERTION OF THE IOL, THE SURGEON OBSERVED THAT THE LENS TURNED AS IT EXITED THE INJECTOR. AS THE INJECTOR WAS RETRACTED FROM THE EYE, THE TRAILING HAPTIC REMAINED IN THE INJECTOR AND THE LENS FLIPPED INSIDE OF THE ANTERIOR CHAMBER. THE CAPSULE BECAME WRAPPED AROUND THE IOL. THE IOL NEEDED TO BE REMOVED AND AN ANTERIOR VITRECTOMY WAS PERFORMED. THE ORIGINAL INCISION WAS 2.6MM AND HAD TO BE ENLARGED TO 6.0MM. AN ANTERIOR CHAMBER IOL WAS IMPLANTED AND SIX SUTURES WERE REQUIRED TO CLOSE THE WOUND. THE PATIENT'S POSTOPERATIVE UNCORRECTED VISUAL ACUITY WAS 20/200. TWO MONTHS POSTOPERATIVELY, THE SUTURES WERE REMOVED, BUT WITHIN 48 HOURS, THE WOUND WAS FOUND RUPTURED AND ENDOPHTHALMITIS DEVELOPED. THE PATIENT'S CURRENT VISUAL ACUITY IS HAND MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS INTRAOCULAR LENS HQL BAUSCH & LOMB, INC. AO60G 1928716

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention