BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMGE SINGLE PIECE FOLDABLE INTRACULAR

    MDR report key: 3030845 · Received March 28, 2013

    Report

    Report Number
    2023826-2013-00238
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 1, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD - LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: METHOD - MEDICAL REVIEW. RESULTS: MEDICAL REVIEW: OD: REPORTEDLY COLLAMER SINGLE-PIECE IOL WAS EXPLANTED/EXCHANGED FOR ANOTHER ONE (SAME MODEL AND DIOPTER) THREE MONTHS POSTOPERATIVELY TO ADDRESS PATIENT SUBJECTIVE VISUAL DISTURBANCES (HALOS AND STREAKS DURING NIGHT DRIVING). ACCORDING TO THE SURGEON THE MOST LIKELY CAUSE OF THE EVENT WAS "CREASE "IN THE EXPLANTED LENS. NO INTRAOPERATIVE OR POSTOPERATIVE COMPLICATIONS WERE REPORTED .THE EXPLANTED LENS WAS NOT RECEIVED FOR THE EVALUATION. THE DEVICE HISTORY RECORD, DRAW A CONCLUSION THAT NOTHING IN THE MANUFACTURING PROCESS CONTRIBUTED TO THE DEVELOPMENT OF A "CREASE". GIVEN THE INFORMATION THAT NO DAMAGE WAS OBSERVED UPON OPENING THE PACKAGE, AS INSTRUCTED IN THE DFU, IT IS VERY LIKELY THAT USER ERROR (SURGEON`S TECHNIQUE) DURING LOADING OR/AND IMPLANTATION COULD HAVE CAUSED/CONTRIBUTED TO THE EVENT. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY REVIEW AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: DEVICE HISTORY REVIEW - THERE WAS NO INFORMATION PROVIDED BY THE SURGEON THAT INDICATED IF THE CREASE WAS PRESENT ON THE LENS WHEN IT WAS RECEIVED OR IT OCCURRED ON REMOVAL FROM PACKAGING. THE LENS WAS NOT AVAILABLE, SO AN EVALUATION COULD NOT BE PERFORMED. HENCE, NO EVIDENT CAUSE CAN BE IDENTIFIED. UPON REVIEW OF THE DEVICE HISTORY RECORD, A CONCLUSION CAN BE DRAWN THAT NOTHING IN THE MANUFACTURING PROCESS CONTRIBUTED TO THE DEVELOPMENT OF A CREASE. AS THE DEFECT WAS NOT NOTICED DURING ELECTION OR PRIOR TO LOADING, THE MOST LIKELY ROOT CAUSE FOR A CREASE ON THE LENS SURFACE IS POOR SURGEON TECHNIQUE OR AN ERROR PRIOR TO OR DURING LOADING IN THE CARTRIDGE. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN); BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND DEVICE HISTORY REVIEW, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NO HE DETERMINED.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS. THE IOL WAS EXPLANTED DUE TO A DEFECT/INDENTATION ON THE LENS. FURTHER INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL IS AVAILABLE.

    Description of Event or Problem · 1

    ADD'L INFO: THE SURGEON REPORTED, STREAKS IN PATIENT'S VISION AND HALOS, PATIENT NOT COMFORTABLE DRIVING DUE TO THESE SYMPTOMS CAUSED BY CREASE IN IOL. ANOTHER LENS, SAME MODEL AND SIZE WAS IMPLANTED. PATIENT'S OD EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127502 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMGE SINGLE PIECE FOLDABLE INTRACULAR INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention CARTRIDGE MODEL AND LOT NUMBER - UNK| INJECTOR MODEL AND LOT NUMBER - UNK