BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 3213391 · Received July 3, 2013

    Report

    Report Number
    2023826-2013-00563
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 6, 2013
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: DEVICE HISTORY REVIEW - AFTER A REVIEW OF THE DEVICE HISTORY RECORD, IT HAS BEEN DETERMINED THAT NOTHING IN THE MANUFACTURING PROCESS OF THE LENS IS CAUSE FOR CONCERN THAT MIGHT HAVE CONTRIBUTED TO THIS COMPLAINT. NO ROOT CAUSE CAN BE IDENTIFIED. CONCLUSIONS: (NO CONCLUSION CAN BE DRAWN); BASED ON THE COMPLAINT HISTORY, LENS WORK ORDER SEARCH AND DEVICE HISTORY REVIEW, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    MEDICAL REVIEW: OD: THE (B)(6) YEAR OLD PATIENT REPORTED, ON (B)(6) 2013, THAT SHE HAD A "CLOUDY VISION LIKE A FOG THAT COMES AND GOES EVERY FIVE MINUTES" FOLLOWING IOL (COLLAMER THREE-PIECE) ONE YEAR AGO. ACCORDING TO THE REPORT RECEIVED FROM THE FACILITY ON (B)(6) 2013, THE LAST EXAM PERFORMED ON (B)(6) 2013, AND THERE WAS NO PATIENT INJURY CAUSED BY THE DEVICE. NO MEDICALLY OR SURGICALLY INTERVENTION WAS PERFORMED OR PLANNED. VA WAS 20/20. THE ONLY FINDING WAS VITREOUS FLOATER UNDER THE OBSERVATION. THE VITREOUS IN PEOPLE OVER 60 SLOWLY SHRINKS WITH AGE, CAUSING THE STRANDS CAST SHADOWS ON THE RETINA (FLOATERS). FLOATERS ARE SPECKS, THREADS, OR COBWEB-LIKE IMAGES THAT OCCASIONALLY DRIFT ACROSS THE LINE OF VISION. FLOATERS APPEAR MORE OFTEN IN THE PEOPLE WHO HAVE HAD CATARACT SURGERY. THEREFORE, THE REPORTED VISUAL DISTURBANCES ARE NOT DEVICE RELATED, BUT CAUSED BY COMBINATION OF A PATIENT FACTOR (AGE) AND PROCEDURE FACTOR (CATARACT SURGERY).

    Description of Event or Problem · 1

    PATIENT STATED THE SURGEON IMPLANTED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS IN RIGHT EYE. PATIENT REPORTED THAT THE LENS IS DEFECTIVE. SHE CAN SEE THE PERIMETER OF THE LENS. A FILM OVER HER EYE, CLOUDY VISION IS LIKE FOG. IT COMES AND GOES, LIKE EVERY 5 MINUTES SHE NOTICES IT WHEN SHE IS WATCHING TV, ALSO LENS MOVEMENT IN THE EYE, LIKE AN EYELASH IN HER EYE. STATED SHE HAS USED THREE DIFFERENT EYE DROPS AT DIFFERENT TIMES. SHE DID NOT KNOWN THE NAME OF THE EYE DROPS. THE DOCTOR REFERRED HER TO A SPECIALIST. THE DOCTOR'S OFFICE HAS BEEN CONTACTED AND FURTHER INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN FORTHCOMING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PHYSICIANS OFFICE REPORTED THE LENS REMAINS IMPLANTED. ON THE PATIENT'S LAST EXAM ON (B)(6) 2013, BCVA 20/20. PATIENT HAS VITREOUS FLOATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305103 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention