BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 2222364 · Received June 24, 2011

    Report

    Report Number
    2023826-2011-00575
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 31, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT CANNOT BE INVESTIGATED FURTHER IN ASSOCIATION TO THE LENS STUCK IN THE INJECTOR AS THE RETURNED INJECTOR, INJECTOR CARTRIDGE AND FOAM TIP PLUNGER HAD NO AVAILABLE LOT NUMBER INFORMATION. BASED ON THE RESULTS OF THE DHR REVIEW, PRODUCT EVALUATION, WORK ORDER SEARCH AND THE LACK OF SUFFICIENT PRODUCT INFORMATION MADE AVAILABLE FROM THE CUSTOMER, A ROOT CAUSE CANNOT BE DETERMINED FOR THIS COMPLAINT.(B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: LENS WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS REC'D STUCK BETWEEN THE FTP AND THE CARTRIDGE. THE TIP OF THE CARTRIDGE WAS DAMAGED, HOWEVER, THERE WAS NO VISIBLE DAMAGE TO THE FTP. THERE WAS EVIDENCE OF A CLEAR SURGICAL RESIDUE. A LENS WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND. CONCLUSION: BASED ON THE COMPLAINT HISTORY, WORK ORDER AND PRODUCT EVAL, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    THE RPTR STATED, AS THE SURGEON ATTEMPTED TO INSERT THE CC4204A COLLAMER SINGLE PIECE WITH ASPHERIC, THE LENS GOT STUCK IN THE INJECTION SYSTEM. THERE WAS NO PT CONTACT.

    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 COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR FTP INDIGO MODEL, LOT NUMBER UNK| CARTRIDGE: MODEL SFC-25FP, LOT NUMBER UNK| INDIGO-P INJECTOR MODEL, LOT NUMBER UNK