BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 2423111 · Received January 18, 2012

    Report

    Report Number
    2023826-2012-00036
    Event Type
    Injury
    Date Received
    January 18, 2012
    Date of Event
    April 26, 2011
    Report Date
    December 20, 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
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A SMALL TEARS ON OPTIC. LENS RETURNED IN LIQUID. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND THE EVAL OF THE RETURNED PRODUCT, IT WAS DETERMINED THAT THE ROOT CAUSE OF THIS EVENT WAS DUE TO WEAK CAPSULE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER ASPHERIC SINGLE PLATE LENS IN PT'S LEFT EYE. THE LENS WAS REMOVED DUE TO WEAK CAPSULE. THE INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. NO CAPSULE BAG DAMAGE, NO VITREOUS LOSS AND NO VITRECTOMY PERFORMED. A COMPETITOR'S LENS WAS IMPLANTED.

    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 CO. CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention FOAM TIP PLUNGER: INDIGO, LOT NUMBER UNK| CARTRIDGE: MODEL SFC-25FP, LOT NUMBER UNK| INJECTOR: MODEL INDIGO P, LOT NUMBER UNK