BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2894101 · Received December 27, 2012

    Report

    Report Number
    2023826-2012-01008
    Event Type
    Injury
    Date Received
    December 27, 2012
    Report Date
    December 3, 2012
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: LENS WORK ORDER SEARCH. MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. MEDICAL REVIEW - GLARE AND HALOS MAY BE NOTED BY PATIENTS EVEN IF THEY NEVER HAD ANY OCULAR SURGERY. THIS IS COMMONLY DUE TO ABERRATIONS OR IRREGULARITIES IN THE CORNEA. IT MAY BE NOTED MORE AT LOW LIGHT CONDITIONS WHEN THE PUPIL IS DILATED ESPECIALLY IF THE PUPIL GOES BEYOND THE OPTIC. THIS IS A DESIGN LIMITATION WHERE LIGHT HITS THE INTERFACE OF THE OPTICAL ZONE AND THE PATIENT'S OPTICAL FIELD OF VISION. THIS CONDITION IS COMMONLY TEMPORARY, LASTING 1-6 MONTHS, BUT MAY ON VERY RARE OCCASIONS BECOME PERMANENT. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE SURGEON IMPLANTED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS IN THE PATIENT'S RIGHT EYE. THE PATIENT COMPLAINT OF GLARE IN BOTH EYES THAT IS DEBILITATING AND ALSO OF ORANGE CIRCLES AT NIGHT FOR BOTH EYES. SHE CONTINUOUSLY HAS LIGHT REFLECTING AND FLICKERING. LENS REMAINS IMPLANTED. THE DOCTOR'S OFFICE WAS CONTACTED. THE PATIENT'S LAST VISIT WAS ON (B)(6) 2012. THE PATIENT IS SCHEDULED TO HAVE A COMPLETE EYE EXAM IN (B)(6). THE LENS IS CENTERED AND THERE WERE NO COMPLICATION DURING SURGERY. VISION IS 20/25+2. SEE MFR# 2023826-2012-01009 FOR LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE: MODEL #UNK, LOT #UNK| INJECTOR: MODEL #UNK, LOT #UNK