BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2092650 · Received May 10, 2011

    Report

    Report Number
    2023826-2011-00394
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 13, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INCISION SUTURED, NO PRODUCT MALFUNCTION. EVALUATION: RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE OPTIC IS TORN. LENS WAS RETURNED IN LIQUID. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS. THE SURGEON PERFORMED AN EXTRACAPSULAR CATARACT EXTRACTION. THE SURGEON MADE A WIDER INCISION TO EXTRACT THE CATARACT. THE LENS WAS INSERTED AND REMOVED DUE TO POSTERIOR CAPSULE TEAR. THE CAPSULE TEAR OCCURRED PRIOR TO LENS IMPLANTATION. THE SURGEON ROUTINELY USED FIVE TO SEVEN SUTURES TO CLOSE THE WOUND. AN ANTERIOR CHAMBER LENS WAS IMPLANTED. REPORTER STATED THERE WAS NO PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention