BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMERR ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCU

    MDR report key: 2963824 · Received February 13, 2013

    Report

    Report Number
    2023826-2013-00120
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 23, 2013
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) - MARKS, GROOVES, SWIRLS ON LENS. EVALUATION METHOD: LENS WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND LENS HAS DRIED UP SURGICAL RESIDUE ON LENS SURFACE. LENS WAS RETURNED DRY. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. CONCLUSION: 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. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: DEVICE HISTORY REVIEW - THERE WAS ON INFORMATION PROVIDED BY THE SURGEON THAT INDICATED IF THE GROOVE WAS PRESENT ON THE LENS WHEN IT WAS RECEIVED OR IT OCCURRED ON REMOVAL FROM PACKAGING. IN ADDITION, AN EVALUATION OF THE RETURNED LENS FAILS TO VERIFY THE COMPLAINT INFORMATION. HENCE, NO EVIDENT CAUSE CAN BE IDENTIFIED. UPON REVIEW OF THE DEVICE HISTORY RECORD AND THE INVESTIGATION PERFORMED, A CONCLUSION CAN BE DRAWN CONSUMER THAT NOTHING IN THE MANUFACTURING PROCESS CONTRIBUTED TO THE PRESENCE OF A MARK OR GROOVE. THE LENS WAS INSERTED INTO CUVETTE AND INSPECTED USING THE "VISLOLA" INSTRUMENT, WHICH PROVIDES A CLEAR VIEW OF ANY SURFACE DEFECT ON THE LENS. EVEN UNDER HIGH MAGNIFICATION, NO DEFECTS COULD HE SEEN. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY 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 OS: REPORTEDLY COLLAMER SINGLE PIECE IOL( 20.0 D) WAS EXPLANTED AND EXCHANGED FOR THE SAME LENS MODEL BUT DIFFERENT POWER (19.0D) TO ADDRESS PATIENT SUBJECTIVE VISUAL DISTURBANCES (GLARE). NO REPORTED LOSS OF BCVA. ACCORDING TO THE SURGEON, THE MOST LIKELY CAUSE OF THE EVENT WAS MANUFACTURING DEFECT ("MARKS", "GROOVES" AND "SWIRLS") SEEN AT THE SLIT LAMP BEFORE EXPLANTATION. 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 IMPLANTED A CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS IN THE PATIENT'S LEFT EYE ON (B)(6) 2012. THE PATIENT EXPERIENCED GLARE AND IT WAS AFFECTING HER VISION. THE SURGEON LOOKED UNDER THE LAMP AND SAW MARKS, GROOVES AND SWIRLS ON THE LENS. THE SURGEON DECIDED TO REMOVE THE LENS. THE SURGEON ENLARGED THE ORIGINAL INCISION TO REMOVE THE LENS. ANOTHER LENS, SAME MODEL BUT WITH DIFFERENT DIOPTER SIZE (19.00) WAS IMPLANTED AND THE SURGEON USED ONE SUTURE TO CLOSE THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64266 COLLAMERR ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCU INTRAOCULAR LENS HQL STAAR SURGICAL CO. CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention CARTRIDGE: MODEL - NANOPOINT - LOT NUMBER - UNK| INJECTOR: MODEL - NANOPOINT - LOT NUMBER - UNK