BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1952073 · Received January 4, 2011

    Report

    Report Number
    2023826-2011-00002
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): LENS WAS THROWN AWAY. DEVICE CODE: NO PRODUCT MALFUNCTION. CONCLUSION: BASED ON THE COMPLAINT HISTORY, THE ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE TO A PT RELATED CONDITION AND WAS NOT LENS RELATED. (B)(4)

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A (B)(4) SILICONE SINGLE PIECE LENS. THE LENS WOULD NOT STAY IN PLACE. THE CAPSULAR BAG HAD A HOLE. THE SURGEON DECIDED TO REMOVE THE LENS AND IMPLANT A THREE PIECE LENS INSTEAD. THE LENS WAS CUT OUT OF THE EYE. THE INCISION WAS ENLARGED AND A SUTURE WAS USED TO CLOSE THE WOUND. THE LENS WAS THROWN AWAY. REPORTER STATED THERE WAS NO PRODUCT MALFUNCTION, IT WAS PT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CO. AA4204VF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CARTRIDGE: MODEL - MTC-60C FP - LOT NUMBER - UNK| INJECTOR: MODEL - MSI-TM - LOT NUMBER - UNK