BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2051258 · Received April 6, 2011

    Report

    Report Number
    2023826-2011-00295
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 14, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - LENS TORE CAPSULE. EVAL: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON TWISTED THE CQ2015A COLLAMER THREE PIECE LENS INTO THE EYE AND IT FELL THROUGH THE POSTERIOR CAPSULE. THE LENS WAS REMOVED, A VITRECTOMY WAS PERFORMED AND AN ACL WAS IMPLANTED. THE REPORTER STATED THE PT DID NOT HAVE ANY PRE-EXISTING ISSUES AND THE LENS CAUSED THE EVENT.

    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 INJECTOR: MODEL MSI-TM, LOT NUMBER UNK| CQ CARTRIDGE-FP: MODEL, LOT NUMBER UNK