BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 2081883 · Received April 5, 2011

    Report

    Report Number
    2023826-2011-00285
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 9, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD - LENS WORK ORDER SEARCH. RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS RECEIVED STUCK IN THE CARTRIDGE AND THE TIP OF THE CARTRIDGE WAS DAMAGED. THERE WAS EVIDENCE OF A CLEAR SURGICAL RESIDUE. A WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND. CONCLUSIONS (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVAL OF THE RETURNED PRODUCT, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD - DEVICE HISTORY REVIEW: RESULTS: THE ROOT CAUSE OF THE SCRATCHED COLLAMER IOL (B)(4) IS UNKNOWN. BASED ON THE AVAILABLE INFORMATION GIVEN WITHIN THIS COMPLAINT, THE RESULTS OF THE DHR REVIEW, WORK ORDER SEARCH, PRODUCT EVALUATION, AND AFTER CHECKING THE TWEEZERS USED AT THE IN-PROCESS AND FINAL INSPECTION, THERE EXISTS THE POSSIBILITY THAT THE LENS MAY HAVE BEEN DAMAGED DURING REMOVAL FROM THE LENS VIAL OR WHILE BEING LOADED INTO THE CARTRIDGE AT THE FACILITY. ANY SHARP TWEEZERS OR INSTRUMENT USED BY THE FACILITY CAN CAUSE THIS TYPE OF DAMAGE TO THE LENS IF THE PRODUCT IS HANDLED INCORRECTLY. QUALITY ENGINEERING CONCLUDES THAT THE PROBABLE CAUSE IS THE FACILITY MOST LIKELY INTRODUCED THIS DEFECT BY INADVERTENTLY MISHANDLING THE LENS UTILIZING A SHARP TOOL DURING REMOVAL FROM THE LENS VIAL OR DURING LENS LOADING INTO THE INJECTOR SYSTEM. CONCLUSION: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, PRODUCT EVALUATION AND DEVICE HISTORY REVIEW, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    THE RPTR STATED THE (B)(4) COLLAMER SINGLE PIECE LENS WAS LOADED AND GIVEN TO THE SURGEON WHO INSPECTED THE LENS AND NOTED A SCRATCH. SURGEON CHANGED TO ANOTHER SAME MODEL LENS AND NEVER ATTEMPTED TO INSERT THIS ONE. THE RPTR WAS UNCERTAIN AS TO WHETHER THE LENS WAS DAMAGED DURING LOADING OR IF IT WAS RECEIVED SCRATCHED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR NANOPOINT INJECTION SYSTEM , LOT NUMBER UNK