BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERFLEX

    MDR report key: 3072368 · Received April 19, 2013

    Report

    Report Number
    9611165-2013-00028
    Event Type
    Injury
    Date Received
    April 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER INTRAOCULAR LENSES LIMITED. THE LITERATURE STATES "SUBSEQUENTLY SHE HAD PHACOEMULSIFICATION WITH HYDROPHILIC ACRYLIC INTRAOCULAR LENS (SUPERFLEX, RAYNER INTRAOCULAR LENS (B)(4); 6.25 MM OPTIC AND 12.5 MM OVERALL LENGTH) IMPLANTATION IN THE BAG WITH ZONULAR DEHISCENCE. VISUAL ACUITY WAS 6/9 IN THE LEFT EYE WITH MILD DECENTRATION. THE PT WAS REFERRED FOR SCLERAL FIXATION OF THE LENS. BECAUSE OF SCLERAL THINNING AND HISTORY OF RETINAL DETACHMENT, WE PROCEEDED WITH IRIS SUTURE FIXATION... TEN HOURS POST-OPERATIVELY, THE PT HAD FINGER COUNTING AT 10 CM WITH FIBRINOUS PANUVEITIS AND DENSE ECHOSE ON B-SCAN. THE POSSIBILITY OF ENDOPHTHALMITIS WAS DISCUSSED WITH THE PT WHO DECLINED IMMEDIATE AQUEOUS PARACENTESIS FOR CULTURE PURPOSES. SHE WAS THEREFORE FOLLOWED UP SEVERAL TIMES DAILY INITIALLY... VISUAL ACUITY IMPROVED TO 6/21 ONE WEEK POSTOPERATIVELY WITH MINIMAL IRITIS... SHE REPORTED A GRADUAL RECOVERY OF PREOPERATIVE VISION 5 WEEKS AFTER SURGERY". DUE TO SCLERAL THINNING AND A HISTORY OF RETINAL DETACHMENT, THE SURGEONS PROCEEDED WITH IRIS SUTURE FIXATION OF THE LENS. THE INFORMATION AVAILABLE WITHIN THE PUBLISHED PAPER INDICATES THAT PT CONDITIONS WERE A CONTRIBUTING FACTOR IN THE DEVELOPMENT OF POST-OPERATIVE FULMINANT PANUVEITIS.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED IDENTIFIED A PUBLISHED PAPER ENTITLED 'FULMINANT PANUVEITIS FOLLOWING IRIS SUTURE FIXATION OF POSTERIOR CHAMBER INTRAOCULAR LENS' DURING A ROUTINE LITERATURE SEARCH. FURTHER REVIEW OF THE PUBLISHED ARTICLE ESTABLISHED THAT A RAYNER INTRAOCULAR LENSES LIMITED MANUFACTURED INTRAOCULAR LENS (SUPERFLEX, MODEL NUMBER NOT STATED) WAS INVOLVED IN THIS INCIDENT. THE LITERATURE STATES "WE PRESENT A CASE OF FULMINANT PANUVEITIS FOLLOWING IRIS SUTURE FIXATION OF A POSTERIOR CHAMBER INTRAOCULAR LENS. WE HYPOTHESIZE THAT THE ZONULAR DEHISCENCE ALLOWED THE INFLAMMATORY CELLS IN THE ANTERIOR COMPARTMENT TO GAIN ACCESS TO THE POSTERIOR SEGMENT MIMICKING ENDOPHTHALMITIS OR TOXIC ANTERIOR SEGMENT SYNDROME".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169881 SUPERFLEX HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention