BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER UV-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE IOL

    MDR report key: 3122185 · Received May 17, 2013

    Report

    Report Number
    2023826-2013-00355
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 23, 2013
    Manufacturer
    STAAR SURGICAL CO.
    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

    (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. 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 RESULTS: A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE OPTIC AND PLATE HAPTIC ARE TORN. 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 THIS EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    RESULTS - DEVICE HISTORY REVIEW: AFTER REVIEWING THE COMPLAINT FILE, DEVICE HISTORY RECORD AND PERFORMING A ROOT CAUSE ANALYSIS, THERE IS NO DIRECT EVIDENCE FOUND TO BE RELATED TO THE MANUFACTURING PROCESS OF THE LENS AS A ROOT CAUSE OF THIS COMPLAINT. THEREFORE IT IS DETERMINED THAT THE ROOT CAUSE OF THE CAPSULE BREAK IS UNKNOWN. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY REPORT REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    MEDICAL REVIEW OD: REPORTEDLY INTRAOPERATIVE IOL (COLLAMER SINGLE- PIECE ASPHERIC LENS) REMOVAL WAS PERFORMED TO ADDRESS POSTERIOR CAPSULAR DAMAGE NOTED UPON INSERTION. VITRECTOMY WAS PERFORMED AND THE SURGEON ATTEMPTED TO IMPLANT 3-PIECE LENS. NO REPORTED POSTOPERATIVE SEQUELAE. GIVEN THE INFORMATION THAT LENS "FELL INTO THE BACK OF THE EYE" IT IS VERY LIKELY THAT POSTERIOR CAPSULAR DAMAGE HAD OCCURRED DURING THE PHACOEMULSIFICATION (BEFORE LENS INSERTION) BUT WAS NOT IDENTIFIED UNTIL THE SURGEON PLACED THE IOL. PER DFU WARNINGS:" THIS IOL SHOULD NOT BE IMPLANTED IF THE POSTERIOR CAPSULE IS RUPTURED OR IF A PRIMARY CAPSULOTOMY IS TO BE PERFORMED." CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY REVIEW, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS IN THE PT'S RIGHT EYE. THE LENS FELL INTO THE BACK OF THE PT'S EYE WHEN IT WAS INSERTED. THE CAPSULE BROKE AND A VITRECTOMY WAS PERFORMED. THE LENS WAS REMOVED AND THE SURGEON ATTEMPTED TO IMPLANT A 3-PIECE LENS. THERE WERE TWO LENSES USED ON THE SAME PT, SAME EYE DURING THE SAME PROCEDURE. THIS REPORT IS FOR THE FIRST LENS. SEE MFR REPORT # 2023826-2013-00356 FOR THE 3-PIECE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219706 COLLAMER UV-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE IOL INTRAOCULAR LENS HQL STAAR SURGICAL CO. CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention INJECTOR, MODEL NANOPOINT, LOT # UNK| CARTRIDGE, MODEL NANOPOINT, LOT # UNK