BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 2980639 · Received February 21, 2013

    Report

    Report Number
    3008772169-2013-00013
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ALCON LENSX LASER INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING CATARACT SURGERY, THERE WAS A RUPTURE OF THE POSTERIOR CAPSULE, AND A LARGE PIECE OF THE NUCLEUS FELL TO THE BACK OF THE EYE. NOT ALL OF THE NUCLEUS THAT FELL COULD BE RETRIEVED. AN ANTERIOR VITRECTOMY WAS PERFORMED, AND A THREE PIECE IOL (INTRAOCULAR LENS) IMPACT WAS PLACED IN THE SULCUS. THE PT WAS OFFERED THE OPPORTUNITY TO SEE A RETINAL SPECIALIST, BUT DECLINED. THE OPERATING SURGEON IS CLOSELY MONITORING THE PT'S VISUAL ACUITY AND INTRAOCULAR PRESSURE. THE CAUSE OF THE POSTERIOR CAPSULE RUPTURE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75234 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX LASER INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention