BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIFLEX

    MDR report key: 3232765 · Received July 18, 2013

    Report

    Report Number
    2648035-2013-00295
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD A SENSAR LENS INSERTED IN THE LEFT EYE AND A NEW INCISION WAS MADE FOR LENS EXPLANTATION (3MM). AS REPORTED BY THE PHYSICIAN, IT IS QUITE POSSIBLE THAT THE ASTEROID HYALOSIS COULD HAVE CONTRIBUTED TO THE DEPOSITS ON THE POSTERIOR LENS SURFACE. HOWEVER, THE DEPOSITS WERE THERE IN THE PRESENCE OF AN INTACT POSTERIOR CAPSULE. THE PATIENT HAD A RIGHT EYE (+20.5D CLARIFLEX - SN (B)(4)) LENS IMPLANTED ON (B)(6) 2005. (THIS LENS REMAINS IMPLANTED). EXPIRATION DATE: 05/31/2009; SERIAL NUMBER: (B)4). CORRECTED DATA: IMPLANT DATE: (B)(6) 2004; EXPLANT DATE: (B)(6) 2013; MANUFACTURE DATE: 05/01/2004. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DATE OF EVENT: (B)(6) 2013. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO OUR MANUFACTURING SITE FOR EVALUATION. THE LENS WAS CLEANED AND EVALUATED BY AN OUTSIDE LABORATORY PRIOR TO RECEIPT AT THE MANUFACTURING SITE. VISUAL INSPECTION REVEALED SURFACE RESIDUALS, HAPTICS (LOOP) DAMAGE, SCRATCHES, AND A TORN LENS. NO CLOUDINESS OR OPACITY WAS OBSERVED. NO COSMETIC CONDITION RELATED TO THE MANUFACTURING PROCESS WAS IDENTIFIED ON THE RETURNED LENS SAMPLE. THE CONDITION OF THE RETURNED LENS WAS CONSISTENT WITH A LENS THAT HAD BEEN EXPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS REVEALED THAT THE INTRAOCULAR LENS (IOL) WAS RELEASED WITHIN SPECIFICATION WITH NO OBSERVATIONS OR NON CONFORMITIES. AT THE FINAL INSPECTION PROCESS IN MANUFACTURING, THE LENSES ARE 100% CLEANED AND INSPECTED AT 10X MICROSCOPE MAGNIFICATION. THE OPERATORS PERFORM A MEASUREMENT INSPECTION AND DISPOSITION ACCORDING TO SPECIFICATIONS FOR VISUAL INSPECTION OF THE SILICONE INTRAOCULAR LENSES. ANY DEFECTS ON THE LENSES THAT DO NOT MEET THE CRITERIA SPECIFICATIONS ARE REJECTED. THE MANUFACTURING RECORD REVIEW RESULTS REVEALED THAT THE LENS MET ALL SPECIFICATIONS DURING THE MANUFACTURING PROCESS. THE INTRAOCULAR LENS (IOL) WAS SENT TO AN OUTSIDE LABORATORY FOR ANALYSIS OF THE CALCIUM LIKE DEPOSITS AS REPORTED BY THE CUSTOMER. THE VISUAL EXAMINATION OF THE LENS AFTER AIR DRYING REVEALED A WHITISH, POWDER-LIKE DEPOSIT ON THE LENS SURFACE WHICH WAS EASILY REMOVED WITH A SCALPEL BLADE. A FOURIER TRANSFORM INFRARED (FTIR) SPECTROSCOPY AND ENERGY DISPERSIVE X-RAY (EDX) SPECTROSCOPY WERE USED. THE EDX ANALYSIS SHOWED PRIMARILY CALCIUM AND PHOSPHORUS WITH A MODERATE AMOUNT OF CARBON, A SMALL AMOUNT OF OXYGEN AND TRACES OF ZINC AND COPPER. A SMALL AMOUNT OF SILICON WAS ALSO SEEN, WHICH MAY BE FROM THE SILICONE LENS MATERIAL. FTIR ANALYSIS OF THE WHITISH DEPOSIT SHOWED CHARACTERISTICS OF AN ESTER MATERIAL MIXED WITH A COMPLEX ORGANIC. THE WHITE DEPOSIT IS PROBABLY A COMPLEX CALCIUM/PHOSPHORUS ORGANIC MIXED WITH AN ESTER OR A MATERIAL WITH ESTER FUNCTIONALITY. IN SUMMARY, THE FTIR AND EDX ANALYSIS SHOWED THAT THE WHITE DEPOSIT WAS PROBABLY A COMPLEX CALCIUM/PHOSPHORUS ORGANIC MIXED WITH AN ESTER OR A MATERIAL WITH ESTER FUNCTIONALITY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO HAD CALCIUM LIKE DEPOSITS WITH THEIR CLARIFLEX LENS, HAD THE LEFT EYE LENS REMOVED AND REPLACED (B)(6) 2013. THE PATIENT DID NOT WANT ANYTHING DONE ON HIS OTHER (RIGHT) EYE WHICH ALSO HAD AN INTRAOCULAR LENS IMPLANT. THE DOCTOR CONFIRMED THAT BOTH OF THE ORIGINAL IMPLANT PROCEDURES WERE UNCOMPLICATED AND THAT A CLARIFEX IOL WAS INSERTED IN BOTH EYES. THE PATIENT WAS NOTED TO HAVE OPACITIES ON THE POSTERIOR CAPSULE OR IOL. A YAG LASER POST CAPSULOTOMY WAS DONE (B)(6) 2007. REPORTEDLY, THE DEPOSITS WERE THEN SEEN ON THE POST LENS SURFACE. IT WAS REPORTED THAT THE PATIENT IS NOW VERY HAPPY. THE PATIENT WAS NOTED TO HAVE ASTEROID HYALOSIS IN BOTH EYES. THE ORIGINAL IMPLANT DATE OF THE LENS IN THE LEFT EYE WAS (B)(6) 2004. THE ORIGINAL IMPLANT DATE OF THE LENS IN THE RIGHT EYE WAS (B)(6) 2005; THIS LENS REMAINS IMPLANTED. THE SERIAL NUMBERS OF THE LENSES ARE UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335980 CLARIFLEX MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS CLRFLX

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention