BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H-10

    MDR report key: 4123701 · Received September 26, 2014

    Report

    Report Number
    2023826-2014-00759
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 29, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - MEDICAL REVIEW. RESULTS - MEDICAL REVIEW: OS: REPORTEDLY AN IOL (THREE-PIECE SILICONE) WAS EXPLANTED THREE WEEKS POSTOPERATIVELY TO ADDRESS LENS DISLOCATION FROM THE SULCUS. EYE WAS LEFT APHAKIC. IT SHOULD BE NOTED THAT EARLY LENS DISPLACEMENT IS USUALLY RELATED EITHER TO THE PATIENT PRE-EXISTING OCULAR CONDITION AND/OR INTRAOPERATIVE COMPLICATIONS AND THEREFORE, NOT SOLELY LENS RELATED IN ORIGIN. AN IOL THAT WAS PLACED IN THE SULCUS AND DECENTERS MAY BE A SIGN OF ZONULO DIALYSIS WITH A HAPTIC THROUGH THE ZONULE. THE REASSESSMENT WILL BE PERFORMED WHEN/IF ADDITIONAL INFORMATION ABOUT PATIENT CURRENT STATUS AND PROGNOSIS IS OBTAINED. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY RECORD REVIEW. RESULTS: DEVICE HISTORY RECORD REVIEW: BASED ON THE INVESTIGATION AND ROOT CAUSE ANALYSIS, THERE IS NOTHING WITHIN THE PRODUCTION PROCESS THAT CAN BE IDENTIFIED TO BE A CONTRIBUTORY FACTOR TO THIS CLAIM. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE).(B)(4): EVALUATION:METHOD - WORK ORDER SEARCH.RESULTS - A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN. 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, 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 IMPLANTED AN AQ2010V THREE PIECE SILICONE LENS IN THE PATIENT'S LEFT EYE ON (B)(6) 2014. THE PATIENT EXPERIENCED A DISLOCATED SULCUS IOL. THE SURGEON EXPLANTED THE LENS ON (B)(6) 2014. THE INCISION WAS NOT ENLARGED, THE LENS WAS CUT TO REMOVE FROM THE EYE. THE LENS WAS NOT EXCHANGED. ONE SUTURE WAS USED TO CLOSE THE WOUND. NO INFORMATION AS TO THE CAUSE OF THE DISLOCATED LENS. NO INFORMATION ON THE PATIENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602387 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention INJECTOR MODEL AND LOT NUMBER - UNK| CARTRIDGE MODEL AND LOT NUMBER - UNK