BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1970386 · Received January 17, 2011

    Report

    Report Number
    2023826-2011-00033
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    November 16, 2010
    Report Date
    December 21, 2010
    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
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAG NOT ABLE TO HOLD LENS. NO PRODUCT MALFUNCTION. EVAL RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND OPTIC TORN. PIECE OF HAPTIC TORN OFF AND MISSING. LENS RETURNED IN VIAL AND IN LIQUID. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND THE EVAL OF THE RETURNED PRODUCT, THE ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE TO A PT RELATED CONDITION AND WAS NOT LENS RELATED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A (B)(4) COLLAMER ASPHERIC SINGLE PLATE LENS. ONCE THE LENS WAS INSERTED INTO THE EYE, THE CAPSULAR BAG WAS IRREGULAR. THE BAG WAS NOT ABLE TO HOLD THE ONE PIECE LENS. THE LENS WAS CUT TO REMOVE FROM THE EYE AND WAS REPLACED WITH A THREE PIECE LENS. NO SUTURES WERE USED. THE CAPSULE BAG DID NOT TEAR AND THERE WAS NO VITRECTOMY PERFORMED. THE REPORTER STATED THE CAUSE OF THIS INCIDENT WAS DUE TO PT RELATED CONDITION AND NOT LENS RELATED.

    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 70 YR Required Intervention FORM TIP PLUNGER: MODEL - INDIGO FORM TIP PLUNGER,| INJECTOR: MODEL - INDIGO-P, LOT NUMBER UNK| CARTRIDGE: MODEL - SFC-25 FP, LOT NUMBER UNK