BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR

    MDR report key: 6789532 · Received August 11, 2017

    Report

    Report Number
    2648035-2017-01470
    Event Type
    Injury
    Date Received
    August 11, 2017
    Report Date
    September 13, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG #: A COMPLETE CATALOG NUMBER IS UNKNOWN SINCE DEVICE SERIAL NUMBER WAS NOT PROVIDED EXPIRATION DATE IS UNKNOWN SINCE DEVICE SERIAL NUMBER WAS NOT PROVIDED UDI IS UNKNOWN SINCE DEVICE SERIAL NUMBER WAS NOT PROVIDED MANUFACTURING DATE: UNKNOWN SINCE DEVICE SERIAL NUMBER IS WAS NOT PROVIDED (B)(4). CITATION: ZHANG Y, HE F, JIANG J, LI Q, WANG Z. MODIFIED TECHNIQUE FOR INTRASCLERAL FIXATION OF POSTERIOR CHAMBER INTRAOCULAR LENS WITHOUT SCLERAL FLAPS. JOURNAL OF CATARACT AND REFRACTIVE SURGERY. FEB 2017;43:162¿166. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE INTRAOCULAR LENSES (IOL) WERE NOT RETURNED TO THE MANUFACTURING SITE. THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED EVENTS COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED SINCE SERIAL NUMBERS ARE UNKNOWN, NOT PROVIDED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICES. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUES COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    FROM THE JOURNAL OF REFRACTIVE SURGERY TITLE: MODIFIED TECHNIQUE FOR INTRASCLERAL FIXATION OF POSTERIOR CHAMBER INTRAOCULAR LENS WITHOUT SCLERAL FLAPS. ABSTRACT: WE PRESENT A MODIFIED TECHNIQUE FOR INTRASCLERAL FIXATION OF A POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) WITHOUT SCLERAL FLAPS AND ASSESS ITS LONG-TERM SAFETY AND EFFICACY. THE HAPTICS OF THE IOL ARE EXTERNALIZED WITH A 23-GAUGE FORCEPS AND FIXATED IN A SCLERAL TUNNEL. TWO CLOCKWISE SCLERAL INCISIONS ARE MADE USING A 23-GAUGE NEEDLE AT AN ANGLE 30 DEGREES ABOVE THE SCLERA. A 3-PIECE IOL IS INSERTED INTO THE ANTERIOR CHAMBER WITH AN INJECTOR THROUGH THE CORNEA INCISION, AND THE TRAILING HAPTIC IS KEPT OUTSIDE TO PREVENT THE IOL FROM FALLING INTO THE VITREOUS CAVITY. THE LEADING HAPTIC IS HELD WITH A FORCEPS AND EXTRACTED FROM THE EYE THROUGH THE SCLERAL INCISIONS. THE TRAILING HAPTIC IS HELD WITH A FORCEPS AND BOTH HAPTICS EXTERNALIZED ONTO THE SCLERA. THE CONJUNCTIVAL INCISIONS ARE CLOSED WITH 8-0 ABSORBABLE SUTURES TIED TO FIXATE 1 HAPTIC (2 O'CLOCK) AFTER 1 MORE BITE ON THE SCLERAL BED. THE POSTOPERATIVE COMPLICATIONS INCLUDED TRANSIENT OCULAR HYPOTONY IN 2 EYES (6%), IOL DISLOCATION IN 1 EYE (3%), AND CYSTOID MACULAR EDEMA (CME) IN 1 EYE (3%). ONE EYE (3%) HAD IOL DISLOCATION 4 WEEKS AFTER SURGERY; THE IOL WAS RECENTERED IN A SUBSEQUENT SURGERY IN WHICH THE HAPTICS WERE ADJUSTED IN THE EXISTING SCLERAL TUNNEL. ONE EYE (3%) DEVELOPED CME, WHICH WAS TREATED WITH A SUB-TENON INJECTION OF TRIAMCINOLONE ACETONIDE 13 WEEKS AFTER SURGERY; SUBSEQUENT SURGICAL INTERVENTION WAS NOT REQUIRED. NO OTHER COMPLICATIONS WERE DETECTED DURING THE FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568117 SENSAR MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention