BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1901404 · Received October 29, 2010

    Report

    Report Number
    2023826-2010-01087
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (NO PRODUCT ALLEGATION AGAINST THE PRODUCT): EVALUATION CODES: RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND SMALL TEAR ON OPTIC. LENS RETURNED IN VIAL AND IN LIQUID. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSIONS - BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, IT WAS DETERMINED THAT THE ROOT CAUSE OF THIS EVENT WAS NOT LENS RELATED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER ASPHERIC SINGLE PLATE LENS. THE CAPSULAR BAG RIPPED AS THE LENS CAME OUT OF THE INJECTOR. THE LENS WAS REMOVED WITH NO WIDENING OF THE INCISION AND NO SUTURE WAS NEEDED. THE CAPSULE TEAR WAS NOT LENS RELATED. THE SURGEON PLANS TO IMPLANT A THREE PIECE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention INJECTOR: MODEL NANOPOINT, LOT NUMBER UNK| CARTRIDGE: MODEL NANOPOINT, LOT NUMBER UNK