BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2821737 · Received November 6, 2012

    Report

    Report Number
    2023826-2012-00880
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE - DATE OF BIRTH - UNKNOWN. PATIENT WEIGHT - UNKNOWN. SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC) WITH TORIC OPTIC. (B)(4) - NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. NO KNOWN DEVICE PROBLEM. EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC AND BOTH HAPTICS TORN. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, THE ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE TO A PATIENT ISSUE AND WAS NOT LENS RELATED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AA4203TF TORIC SILICONE SINGLE PIECE LENS BUT THE LENS WAS REMOVED DUE TO THE PATIENT DID NOT HAVE ANY ZONULES, AND THE SURGEON WAS UNABLE TO PLACE THE LENS IN THE EYE. THE LENS WAS CUT OUT OF THE EYE TO REMOVE WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES AND A THREE PIECE LENS WAS IMPLANTED IN THE SULCUS. NO VITRECTOMY WAS PERFORMED. THE REPORTER STATED THE EVENT WAS DUE TO A PATIENT ISSUE AND WAS NOT LENS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE: MODEL AND LOT NUMBER UNK| INJECTOR: MODEL AND LOT NUMBER UNK