BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 4476799 · Received February 2, 2015

    Report

    Report Number
    2648035-2015-00035
    Event Type
    Injury
    Date Received
    February 2, 2015
    Report Date
    January 15, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN FOLLOW UP IT WAS LEARNED THAT THE INCISION HAD TO BE ENLARGED TO EXPLANT THE INTRAOCULAR LENS. PATIENT HAD CYSTOID MACULAR EDEMA IN (B)(6) 2014 THAT WAS TREATED WITH YELLOX; NO IOL PROBLEM. AFTER IOL WAS EXPLANTED THE SURGEON DECIDED TO ADJUST THE TARGETED REFRACTIVE OUTCOME AND A +16.50 DIOPTER IOL WAS IMPLANTED; THE PATIENT'S VISUAL ACUITY IS 10/10. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PT AGE AND GENDER: ASKED, NOT PROVIDED. SERIAL NUMBER AND EXPIRATION; ASKED NOT PROVIDED. IMPLANT AND EXPLANT DATES: UNKNOWN. INITIAL REPORTER PHONE: (B)(6). SECTION F COMPLETED BY THE MANUFACTURER (B)(4). PMA 510(K): THIS DEVICE IS NOT MARKETED/APPROVED IN THE USA. IT IS SAME/SIMILAR TO THE ZCB00 PMA P980040. UNKNOWN SINCE THE SERIAL NUMBER IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP INFORMATION FROM THE SURGEON WAS PROVIDED: THE ORIGINAL TARGET WAS RIGHT EYE (OD) SPH -2.20, WITH AN IOL OF 19.0 D. (ZEISS IOL-M, SRK/T). POSTOP. SPH -4.25. WE DID FIRST SURGERY ON THE OTHER EYE, TARGET LEFT EYE (OS) SPH -2.00, WHICH WAS WITH IOL OF 17.0 DIOPTER POSTOP CORRECT; SPHERICAL EQUIVALENT (SE) SPH -2.25. AFTER THIS WE DID A NEW IOL M FOR OD. WE LOWERED THE TARGET TO SPHERE -1.50 (AS AGREED WITH PATIENT) THE IOL WHAT SHOULD MATCH WITH THIS WAS 18.0 DIOPTER. SE FROM EARLIER YEARS OD STILL APPROX. -4.50, OS APPROX. S -5.00 THIS LAST INFO WAS THE REASON TO SEE FIRST OS EN NOW TO MAKE SURE OD GETS APPROX. THE SAME TARGET. THIS WITH THE RISK TO COME ON APPROX.. S.-1 >>. IOL 16.5 THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION SHOWED SMALL LOOSE PARTICLES WERE OBSERVED ON THE SAMPLE COMPATIBLE WITH HANDLING THE LENS OUT OF A PARTICLE CONTROLLED ENVIRONMENT. STAINS OF VISCOELASTIC WERE DISPERSED THROUGH THE LENS OPTICAL ZONE AND HAPTICS. THE LENS HAD COSMETIC DAMAGES (SCRATCHES, CHIPPED EDGES) THAT COULD BE RELATED TO THE EXPLANT PROCESS. THE RETURNED LENS DID NOT MEET VISUAL INSPECTION CRITERIA. HOWEVER, THE LENS DEFECTS ARE COMPATIBLE WITH A LENS THAT HAS BEEN EXPLANTED. THERE WAS NO INDICATION THE FAILURE WAS RELATED TO THE REPORTED COMPLAINT OR RELATED TO THE MANUFACTURING PROCESS. DIOPTER TESTING WAS CONDUCTED THREE TIMES ON THE RETURNED LENS. THE AVERAGE MEASURED POWER EQUALS 19.0 DIOPTERS, THE LABELED POWER. DEVICE MET RELEASE SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORD REVIEW WAS PERFORMED FOR SERIAL NUMBER (B)(4) OF THE ACRYLIC LENS PCB00 (TECNIS ITEC PRELOADED 1-PIECE) DIOPTER 19.0. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTION SPECIFICATIONS. NO DEVIATION OR NONCONFORMANCE (NCR) RELATED TO THE CUSTOMER CLAIM WAS GENERATED. THE LENS DIOPTER RESULTS OBTAINED FROM THE STORED DATA SHOWED THAT THE LENS CORRESPONDED TO A 19.0 DIOPTER LENS. THE RESULTS OF THE FUNCTIONAL TESTING PERFORMED IN THIS PRODUCTION ORDER WERE FOUND WITHIN SPECIFICATIONS. A REVIEW OF PROCESS MANUFACTURING INSTRUCTIONS THE CHANGE CONTROL SYSTEM WAS DONE DURING THE PERIOD WHEN THIS PRODUCTION ORDER WAS MANUFACTURED AND DID NOT SHOW ANY CHANGE IN THE MANUFACTURING METHOD OR SPECIFICATIONS THAT COULD BE RELATED FOR THIS COMPLAINT TYPE. THE DOCUMENTATION SHOWED THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: FOLLOW-UP NO 2 SHOULD HAVE HAD DEVICE EVALUATION BOX CHECKED FOR THE MANUFACTURING RECORD REVIEW. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT A TECNIS PRE-LOADED 1-PIECE INTRAOCULAR LENS (IOL) WAS EXPLANTED AFTER THE PATIENT EXPERIENCED UNEXPECTED POST-OP REFRACTION. THE IOL WAS REPLACED WITH ANOTHER PCB00 AND THE PATIENT HAD A GOOD REFRACTIVE OUTCOME. THE SURGEON NOW WONDERS IF THE EXPLANTED IOL IS THE SAME DIOPTER AS WAS LABELED ON THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74595 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention