BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 2552650 · Received April 25, 2012

    Report

    Report Number
    3008772169-2012-00018
    Event Type
    Injury
    Date Received
    April 25, 2012
    Date of Event
    January 1, 2011
    Report Date
    March 26, 2012
    Manufacturer
    ALCON - LENSX LASERS, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO UNUSUAL FINDINGS RELATED TO THE REPORTED ADVERSE EVENTS. THE AUTHOR DID NOT PROVIDE DETAILS TO IDENTIFY SPECIFIC PTS AND THE ROOT CAUSE OF THE TEARS, BUT THE AUTHOR DID STATE THAT THE LASER DID NOT PERFORATE OR RUPTURE THE POSTERIOR CAPSULE. CAPSULAR TEARS ARE AN INHERENT RISK OF CATARACT SURGERY. THE AUTHOR CONCLUDED THAT THERE IS A LEARNING CURVE ASSOCIATED WITH THE TECHNOLOGY AND THE RATE OF COMPLICATIONS DECREASES WITH SURGICAL EXPERIENCE. THE MANUFACTURER REVIEWED THE PUBLISHED LITERATURE REGARDING CAPSULAR COMPLICATIONS AND CONCURS WITH THE AUTHORS THAT THE COMPLICATION RATE IS DIRECTLY CORRELATED WITH SURGICAL EXPERIENCE. IT SHOULD BE NOTED THAT 2 MDRS WERE PREVIOUSLY SUBMITTED FOR REPORTS OF CAPSULAR BLOCK SYNDROME, WHICH WERE REPORTED IN THIS ARTICLE. REFERENCE MDRS NUMBERS: 3008772169-2011-00001 AND 3008772169-2011-00002. (B)(4).

    Description of Event or Problem · 1

    BASED ON THE ATTACHED PUBLISHED ARTICLE: 2012 BY THE AMERICAN ACADEMY OF OPHTHALMOLOGY PUBLISHED BY ELSEVIER INC, "EARLY EXPERIENCE WITH THE FEMTOSECOND LASER FOR CATARACT SURGERY" THE FOLLOWING COMPLICATIONS WERE NOTED OUT OF 200 SUBJECTS: "POSTERIOR CAPSULAR TEAR AND VITREOUS LOSS" (4 EYES) AND "POSTERIOR (NUCLEUS) LENS DISLOCATION" (1 EYE). THE AUTHORS STATED, "IT SHOULD ALSO BE MADE CLEAR THAT IN NO CASES DID THE FEMTOSECOND LASER PERFORATE OR RUPTURE THE POSTERIOR CAPSULE". THIS REPORT IS FOR ADVERSE EVENTS PRESENTED FOR GROUP 1 IN THE REFERENCED ARTICLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention