BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADAPTAO INTRAOCULAR LENS

    MDR report key: 8974728 · Received September 9, 2019

    Report

    Report Number
    0001313525-2019-00138
    Event Type
    Injury
    Date Received
    September 9, 2019
    Date of Event
    February 5, 2018
    Report Date
    July 25, 2019
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE IOL WAS SENT TO THE LABORATORY FOR EVALUATION THE REPORT CONCLUDED THAT THE PRIMARY OPACIFYING FEATURES ARE COMPRISED PRIMARILY OF CALCIUM AND PHOSPHOROUS, WHICH IS CONSISTENT WITH HISTORICAL PRODUCT RETURNS. CARBON AND OXYGEN ARE PRESENT DUE TO THE NODULES BEING BELOW THE SURFACE OF THE LENS. A SMALL AMOUNT OF SODIUM IS ALSO PRESENT, THIS MAY BE RESIDUAL FROM THE PACKING SOLUTION. THE GOLD AND PALLADIUM PRESENT IN BOTH SPECTRA ARE FROM THE CHARGE CONTROL SPUTTER COATING. THERE HAVE BEEN NO OTHER COMPLAINTS FOR THIS LOT TO DATE. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND DIRECTIONS FOR USE REVIEW ARE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION IS NECESSARY AT THIS TIME. THE MOST PROBABLE ROOT CAUSE IS KNOWN PROCEDURE COMPLICATION. PER DIRECTIONS FOR USE PRECIPITATES ON THE SURFACE OF THE IOL IS A KNOWN PROCEDURE COMPLICATION. THREE (3) MAJOR TYPES OF CALCIFICATION HAVE BEEN IDENTIFIED. THE PRIMARY FORM REFERS TO CALCIFICATION IS CAUSED BY FACTORS INHERENT TO THE IOL DESIGN OR MATERIAL. THE SECONDARY FORM REFERS TO DEPOSITION OF CALCIUM ONTO THE SURFACE OF THE IOL CAUSED BY ENVIRONMENTAL FACTORS (E.G. CHANGES IN THE AQUEOUS SURROUNDING THE IMPLANTED IOL ASSOCIATED WITH PRE-EXISTING OR CONCURRENT DISEASES, OR DUE TO ADDITIONAL SURGICAL INTERVENTION). BY DEFINITION, IT IS NOT RELATED TO ANY PROBLEM WITH THE IOL ITSELF. THE THIRD FORM IS A FALSE-POSITIVE OR PSEUDO-CALCIFICATION IN WHICH OTHER PATHOLOGY IS MISTAKEN FOR CALCIFICATION OR FALSE-POSITIVE STAINING FOR CALCIUM OCCURS. VARIOUS MECHANISMS EXPLAINING THE FORMATION OF MINERAL DEPOSITS HAVE BEEN SUGGESTED. THE UNDERLYING PATHOGENETIC MECHANISMS OF DELAYED POSTOPERATIVE CALCIFICATION REMAINS UNKNOWN AND A BROAD SPECTRUM OF BIOLOGICAL, PHARMACOLOGICAL, TECHNOLOGICAL, AND/OR CERTAIN TOPICAL ENVIRONMENTAL FACTORS MAY BE INVOLVED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION. ONE IOL WAS RETURNED IN A SMALL PLASTIC VIAL. THE ORIGINAL PACKAGING WAS NOT RETURNED. THE PART NUMBER AND SERIAL NUMBER OF THE LENS CANNOT BE VERIFIED. HOWEVER, THE LENS DOES HAVE THE APPEARANCE OF AN ADAPTAO LENS. THE VIAL WAS FILLED WITH AN UNKNOWN SOLUTION. VISUAL INSPECTION FOUND THE OPTIC WAS CUT NEARLY IN HALF. THE OPTIC HAD A CLOUDY WHITE APPEARANCE AND SOME AREAS WITH AN ORANGE PEEL APPEARANCE ON THE SURFACE. FURTHER INVESTIGATION IS UNDERWAY. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿S AKREOS INTRAOCULAR LENS (IOL) DEVELOPED OPACIFICATION IN THE RIGHT EYE FOUR YEARS POST IMPLANTATION RESULTING IN AN EXPLANT FIVE YEARS AND FOUR MONTHS POST IMPLANT WHICH REQUIRED A VITRECTOMY. THE ORIGINAL PROCEDURE WAS NOT COMPLICATED IN ANYWAY. THE OPERATION WAS ONLY A PHACO AND LENS IMPLANT. THERE WAS NO COMPLICATION DURING THE OPERATION, AND POST OPERATIVELY EVERYTHING WAS WELL. THE ORIGINAL INCISION SIZE WAS 2.6MM AND THE PROCEDURE WAS LESS THAN 15 MINUTES. THERE WAS NO EVIDENCE OR SUSPICION OF A WOUND LEAK POSTOPERATIVELY. THE MEDICAL FACILITY REPORTED THAT STANDARD METHODS HAVE BEEN FOR THE PAST 10 YEARS TO DECONTAMINATE / STERILISE THE HANDPIECE PRIOR TO SURGERY, INCLUDING ENDOZIME CLEANING AND THEN GRAVITY STEAM STERILIZATION. POST OP ANTI INFLAMMATORY AND ANTIBIOTIC REGIMEN WAS COMPLETED BY THE PATIENT INCLUDING SPERSEDEX, ACULAR AND TOBREX OINTMENT. THE PATIENT'S INTRAOCULAR PRESSURE (IOP) WAS NOT ELEVATED POST OPERATIVELY AND THE PATIENT HAD AVASTIN INJECTIONS AFTER IOL IMPLANT. ON A CONSULTATION TWO MONTHS POST IMPLANT THE VISION IN THE RIGHT EYE WAS 0.7-2 AND DETERIORATED TEN MONTHS POST IMPLANT TO ONLY HAND MOVEMENT. AT THAT TIME THE RIGHT CORNEA WAS DRY SO YAG LASER WAS NOT POSSIBLE. YAG LASER WAS COMPLETED ELEVEN MONTHS POST IMPLANTATION BUT THE VISION SHOWED NO IMPROVEMENT. OPACIFICATION STARTED FOUR YEARS POST IMPLANTATION. THE LENS WAS EXPLANTED FIVE YEARS AND FOUR MONTHS POST IMPLANT WITH A DIFFERENT LENS MODEL OF A DIFFERENT DIOPTER. THE SURGEON COULD NOT INDICATE A LIKELY CAUSE OF THE EVENT AND THE PATIENT CURRENT PROGNOSIS IS GOOD, AS THE NEW IOL LENS IS CRYSTAL CLEAR. VISUAL ACUITY HAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768521 AKREOS ADAPTAO INTRAOCULAR LENS INTRAOCULAR LENS HQL BAUSCH + LOMB ADAPTAOP 1372426

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention