BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H-10

    MDR report key: 2862826 · Received December 10, 2012

    Report

    Report Number
    2023826-2012-00967
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 16, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT - UNK. COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4). METHOD - WORK ORDER SEARCH RESULTS - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS - NO CONCLUSION CAN BE DRAWN: BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD - DEVICE HISTORY RECORD REVIEW. RESULTS - A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND IT WAS FOUND, AFTER GOING THROUGH THE DEVICE HISTORY RECORD, IT HAS BEEN DETERMINED THAT THERE IS NO EVIDENT CAUSE FOR THIS COMPLAINT. PROBABLE CAUSES WOULD INCLUDE LATHE MARKS CAUSED BY DEFECTIVE LATHING TOOLS AND/OR INADEQUATE TUMBLING. BASED ON THE PROBABLE CAUSES STATED ABOVE AND THE INVESTIGATION CONDUCTED, THE MOST LIKELY ROOT CAUSE FOR THE PRESENCE OF A BULLS-EYE ON THE LENS IS A LESS THAN SATISFACTORY LATHING PROCESS. CONCLUSIONS - BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, THE MOST LIKELY ROOT CAUSE OF THE EVENT IS A LESS THAN SATISFACTORY LATHING PROCESS. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A BULLS-EYE PATTERN ON THE LENS SURFACE, IN THE LENS OPTIC AREA. ONE HAPTIC WAS TORN. THE LENS WAS RETURNED IN LIQUID AND THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A (B)(4) COLLAMER ASPHERIC SINGLE PIECE LENS AND THE SURGEON NOTED A BULLS-EYE PATTERN ON THE LENS. THE INCISION WAS ENLARGED TO REMOVE THE LENS DURING THE SAME SURGERY AND ANOTHER SAME MODEL LENS WAS IMPLANTED. SUTURES WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention INJECTOR: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL AND LOT NUMBER UNK