BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H-10

    MDR report key: 2781539 · Received October 10, 2012

    Report

    Report Number
    2023826-2012-00757
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 14, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4) - MEMBRANE, BREAKAGE OF, SURGICAL INCISION, ENLARGEMENT OF. (B)(4). DEVICE EVALUATED BY MANUFACTURER? NO: LENS WAS DISCARDED AT THE SURGERY CENTER. 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). LENS WAS DISCARDED AT THE SURGERY CENTER.

    Additional Manufacturer Narrative · 1

    EVALUATION:METHOD - DEVICE HISTORY RECORD REVIEW.RESULTS - A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NOTHING WAS FOUND IN THE MANUFACTURING PROCESS OF THIS LENS THAT WAS RELATED TO THE ROOT CAUSE OF THE COMPLAINT. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN):BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE DEVICE HISTORY RECORD REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.(B)(4).

    Additional Manufacturer Narrative · 1

    METHOD - MEDICAL REVIEW. RESULTS - MEDICAL REVIEW - A POSTERIOR CAPSULE TEAR IS MORE COMMONLY SECONDARY TO SURGICAL MANIPULATIONS PERFORMED BY THE SURGEON DURING INTRAOCULAR SURGERY HOWEVER, IT REMAINS UNCLEAR WHETHER THE PRODUCT CAUSED OR CONTRIBUTED TO THIS EVENT. ENLARGEMENT OF AN INCISION MAY CAUSE INDUCED ASTIGMATISM, HOWEVER, IT IS DEPENDENT ON THE LENGTH OF THE INCISION. WHEN A DAMAGED LENS IS REMOVED, INCISION IS USUALLY ENLARGED TO A LENGTH THAT WOULD NOT CREATE ANY SERIOUS INJURY. CONCLUSIONS - BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND MEDICAL REVIEW, 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 CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS AND NOTED THE CAPSULE BAG WAS TORN. THE INCISION WAS ENLARGED SLIGHTLY TO REMOVE THE LENS AND A THREE PIECE LENS WAS IMPLANTED. SUTURES WERE NOT REQUIRED AND NO VITRECTOMY PERFORMED. THE REPORTER STATED THE FACILITY USES A COMPETITOR'S PHACOEMULSIFICATION SYSTEM. THE LENS WAS DISCARDED AT THE SURGERY CENTER.

    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 Required Intervention CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK