BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H-10

    MDR report key: 4101928 · Received September 19, 2014

    Report

    Report Number
    2023826-2014-00733
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 21, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MJP
    PMA / PMN Number
    P880091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC®) WITH TORIC OPTIC (B)(4). EVALUATION CODES: METHOD -(OTHER): WORK ORDER SEARCH RESULTS - (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS WAS RETURNED IN THREE PIECES. A FOURTH PIECE, HAPTIC AND PIECE OF OPTIC IS TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE ON PRODUCT. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND. CONCLUSIONS -(NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE 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

    METHOD: MEDICAL REVIEW. RESULTS: MEDICAL REVIEW: OD: REPORTEDLY AN IOL (SILICONE SINGLE PIECE WITH TORIC OPTIC) WAS EXPLANTED/EXCHANGED FOR COMPETITOR`S LENS MORE THAN FOUR MONTHS POSTOPERATIVELY TO ADDRESS PATIENT SUBJECTIVE SYMPTOMS (HALOS, GLARE). ACCORDING TO THE REPORT FROM THE FACILITY, THE VA BEFORE EXPLANTATION WAS 20/50 (NOT SPECIFIED IF THAT WAS CORRECTED OR UNCORRECTED). THE REPORTED EVENT WAS ATTRIBUTED TO PATIENT FACTOR ("PATIENT COULD NOT SEE WITH THE LENS") AND WAS NOT RELATED TO THE DEVICE. IT SHOULD BE NOTED THAT DIOPTER OF A REPLACEMENT LENS AND STATUS OF THE FELLOW EYE WERE NOT PROVIDED SINCE IT IS KNOWN THAT PRE-OP MISCALCULATION COULD CAUSE REPORTED SYMPTOMS. ALL IOLS INCREASE INTERNAL AND EXTERNAL SURFACE REFLECTIONS WHEN COMPARED TO THE HUMAN CRYSTALLINE LENS AND MAY CAUSE UNWANTED IMAGES. THE BRAIN IS ADAPTED AT ELIMINATING UNWANTED VISUAL INPUT BY PHENOMENON OF CENTRAL ADAPTATION. THERE ARE A LOT OF UNWANTED IMAGES IN OUR FIELD OF VISION, BUT OUR BRAIN ADAPTS AND ELIMINATES THEM ALL. IT IS INEVITABLE THAT SOME PATIENTS WILL EXPERIENCE UNWANTED IMAGES FOLLOWING IOL IMPLANTATION SO IT VERY IMPORTANT TO CREATE ACCURATE EXPECTATIONS BEFORE SURGERY, AND MINIMIZE PROBLEM SURGICALLY (ADEQUATE SIZE OF CAPSULORHEXIS, WELL CENTERED LENS IN THE BAG, ETC. PREVENT UNNECESSARY PROBLEMS). 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).

    Description of Event or Problem · 1

    THE REPORTER STATED THE PHYSICIAN IMPLANTED A AA4203TL SILICONE SINGLE PIECE LENS WITH TORIC OPTIC IN THE PATIENT'S RIGHT EYE ON (B)(6) 2014. THE PATIENT EXPERIENCED IMPAIRED VISION, GLARE DISABILITY AND DYSPHOTOPSIA-POSITIVE. PATIENT'S VA WAS 20/50 A FEW DAYS AFTER THE IMPLANT. THE LENS WAS EXPLANTED ON (B)(6)2014 AND A COMPETITORS TORIC LENS WAS IMPLANTED. THERE WAS NO PATIENT INJURY. THE REPORTER STATED THIS INCIDENT WAS PATIENT RELATED, THE PATIENT COULD NOT SEE WITH THE LENS. THERE WAS NO PROBLEM WITH THE LENS ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582676 SEE H-10 INTRAOCULAR LENS MJP STAAR SURGICAL COMPANY AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention CARTRIDGE MODEL - MTC-60C FP - LOT NUMBER - UNK| INJECTOR MODEL - MSI-TR - LOT NUMBER - UNK