BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H-10

    MDR report key: 2780356 · Received October 10, 2012

    Report

    Report Number
    2023826-2012-00703
    Event Type
    Injury
    Date Received
    October 10, 2012
    Report Date
    September 11, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4) - SURGICAL PROCEDURE, SECONDARY SURGERY, (REFRACTIVE ERROR). (B)(4) - EXPLANTED. METHOD - WORK ORDER SEARCH. RESULTS - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC TORN, WITH A PIECE TORN OFF AND MISSING. THE LENS WAS RETURNED IN LIQUID AND THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. 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).

    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 THE ROOT CAUSE OF THE COMPLAINT. CONCLUSIONS - BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW, DEVICE HISTORY RECORD REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A PROBABLE ROOT CAUSE OF THE EVENT WAS DUE TO A COMBINATION OF THE PATIENT'S PREVIOUS REFRACTIVE SURGERY AND THE SURGEON'S INACCURATE CALCULATION OF THE APPROPRIATE LENS POWER FOR THE PATIENT DUE TO THE PREVIOUS SURGERY. THERE WAS NO PRODUCT DEFECT. (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD - MEDICAL REVIEW. RESULTS - MEDICAL REVIEW - REVIEW OF THIS FILE INDICATES THAT THE SURGEON'S TARGET REFRACTION WAS NOT CONSISTENT WITH THE PATIENT'S POST-OP REFRACTION. THIS PATIENT HAD A HISTORY OF REFRACTIVE LASER SURGERY IN THE PAST THEREFORE THE CENTRAL CORNEAL REFRACTIVE POWER CANNOT BE APPROXIMATED BY A SPHERE, AND THE POSTERIOR CORNEAL RADIUS OF CURVATURE WHICH IS NORMALLY DETERMINED TO BE 1.2 MM LESS THAN THE ANTERIOR RADIUS ARE NO LONGER TRUE. THE FORMULAS USED TO CALCULATE FOR THE POST-OP REFRACTION IN REGULAR EYES SHOULD NOT BE USED IN THIS CASE BECAUSE DESIRED RESULTS WILL NOT BE ACHIEVED SINCE THE CENTRAL CORNEAL POWER WILL BE MEASURED INCORRECTLY. CURRENT FORMULAS TO ADDRESS THIS ISSUE HAVE BEEN DEVELOPED BUT HAVE NOT BEEN ACCURATE TO DATE. THE RESULTING ERRORS ARE DUE TO MISCALCULATION FOLLOWING KERATOREFRACTIVE SURGERY, BECAUSE THE MEASURED CORNEAL POWERS ARE USUALLY GREATER THAN THE TRUE REFRACTIVE POWER OF THE CORNEA. THE MOST PROBABLE ROOT CAUSE OF THIS EVENT HAS BEEN DETERMINED TO BE DUE TO THE PATIENT'S PREVIOUS LASER REFRACTIVE SURGERY AND NO ACCURATE FORMULAS HAVE BEEN DEVELOPED TO PREDICT THE TARGET REFRACTION PRECISELY. CONCLUSIONS - BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, THE MOST PROBABLE ROOT CAUSE OF THIS EVENT HAS BEEN DETERMINED TO BE DUE TO THE PATIENT'S PREVIOUS LASER REFRACTIVE SURGERY AND NO ACCURATE FORMULAS HAVE BEEN DEVELOPED TO PREDICT THE TARGET REFRACTION PRECISELY. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2012. THE LENS WAS EXPLANTED ON (B)(6) 2012, DUE TO A REFRACTIVE ERROR. ANOTHER SAME MODEL BUT DIFFERENT DIOPTER LENS WAS IMPLANTED.

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