BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H-10

    MDR report key: 4183146 · Received October 17, 2014

    Report

    Report Number
    2023826-2014-00843
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: COLLAMER® ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4). METHOD: LENS WORK ORDER SEARCH RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. CONCLUSION: CONCLUSION NOT YET AVAILABLE. EVALUATION IS IN PROGRESS. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: NO VITRECTOMY WAS PERFORMED. RESULTS: A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. LENS WAS RETURNED IN LIQUID. BOTH SIDES OF THE OPTIC/HAPTIC WERE CHECKED FOR ROUGH/SHARP EDGES. EDGES WERE FOUND TO BE ACCEPTABLE. CONCLUSION: CONCLUSION NOT YET AVAILABLE. EVALUATION IS IN PROGRESS. (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: MEDICAL REVIEW AND DEVICE HISTORY REPORT REVIEW. RESULTS: MEDICAL REVIEW: REVIEW OF THE COMPLAINT FILE INDICATES THAT A SINGLE PIECE CC4204A IOL WAS INSERTED AND REMOVED DUE TO THE TORN CAPSULE. NO VITRECTOMY WAS PERFORMED. NO ADDITIONAL INFORMATION IS KNOWN. SURGICAL TECHNIQUES (SUCH AS CAPSULORRHEXIS AND PHACOEMULSIFICATION) AND PATIENTS' CONDITION SUCH AS MATURE CATARACT, DIABETES AND CAPSULE DYNAMICS (I.E. CAPSULAR CONTRACTION SYNDROME) COULD CONTRIBUTE TO CAPSULE TEAR. THERE IS NO EVIDENCE SUPPORT THAT THE MEDICAL DEVICE IS THE CAUSE OF THE EVENT. DEVICE HISTORY REPORT REVIEW: AFTER PERFORMING A REVIEW OF THE DEVICE HISTORY RECORD AND A ROOT CAUSE ANALYSIS, THERE IS NO IDENTIFIABLE ROOT CAUSE FOR THIS COMPLAINT. THE MANUFACTURING PROCESS OF THE LENS HAS BEEN REVIEWED AND INDICATES THAT THE LENSES MET ALL REQUIREMENTS; THEREFORE, IT IS HIGHLY UNLIKELY THAT ANYTHING IN THE MANUFACTURING PROCESS IS THE ROOT CAUSE OF THIS COMPLAINT. THE MOST LIKELY ROOT CAUSES FOR THE CAPSULE TEAR ARE SURGEON TECHNIQUE OR PATIENT RELATED ISSUES, WHICH CANNOT BE RULED OUT BUT ALSO CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED IN THE CLAIM. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY REPORT REVIEW, 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 SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS IN THE PATIENT'S EYE. THERE WAS A CAPSULE TEAR. LENS WAS REMOVED. FURTHER INFORMATION HAS BEEN REQUESTED, BUT NONE HAS BEEN FORTHCOMING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660232 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| FOAM TIP PLUNGER AND LOT NUMBER - UNK| INJECTOR MODEL AND LOT NUMBER - UNK