BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 4490318 · Received February 5, 2015

    Report

    Report Number
    1119421-2015-00082
    Event Type
    Injury
    Date Received
    February 5, 2015
    Report Date
    November 19, 2014
    Manufacturer
    ALCON RESEARCH, LTD./ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORT DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THE COMPLAINT FILE WAS OPENED FROM A LITERATURE REPORT: APODIZED DIFFRACTIVE INTRAOCULAR LENS IMPLANTATION AFTER LASER IN SITU KERATOMILEUSIS WITH OR WITHOUT SUBSEQUENT EXCIMER LASER ENHANCEMENT. NOT ENOUGH INFORMATION WAS PROVIDED IN THE REPORT FOR FURTHER INVESTIGATION. NO MALFUNCTION WAS INDICATED AGAINST THE IOL USED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE AND MAIL. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. MUFTUOGLU, O, APODIZED DIFFRACTIVE INTRAOCULAR LENS IMPLANTATION AFTER LASER IN SITU KERATOMILEUSIS WITH OR WITHOUT SUBSEQUENT LASER ENHANCEMENT; J CATARACT REFRACT SURG 2010; 36:1815-1821. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE ENTITLED, "APODIZED DIFFRACTIVE INTRAOCULAR LENS IMPLANTATION AFTER LASER IN SITU KERATOMILEUSIS WITH OR WITHOUT SUBSEQUENT EXCIMER LASER ENHANCEMENT," THE STUDY COMPRISED OF PATIENTS WHO HAD IOL IMPLANTATION BETWEEN DECEMBER 2005 AND NOVEMBER 2008 AFTER PREVIOUS LASIK. INCLUDED WERE EYES THAT HAD REFRACTIVE SURGERY ENHANCEMENT WITH AN EXCIMER LASER AND EYES THAT HAD NEODYMIUM: YAG CAPSULOTOMY. OF THE 49 EYES (38 PATIENTS), 21 EYES HAD LASER ENHANCEMENT AND 25 EYES HAD A YAG CAPSULOTOMY. THERE WERE 11 EYES THAT HAD IMPLANTATION OF ONE MULTIFOCAL IOL MODEL, AND 38 EYES WERE IMPLANTED WITH A DIFFERENT MODEL MULTIFOCAL IOL. THERE WERE 2 EYES IN THE ENHANCEMENT GROUP THAT DEVELOPED PERIPHERAL EPITHELIAL NESTS/INGROWTH AND THE CONDITION REMAINED STABLE UNTIL THE END OF FOLLOW UP. OVERALL, 9 EYES DEVELOPED MILD DRY EYE; 3 EYES WERE IN THE NO ENHANCEMENT GROUP, AND 6 EYES WERE IN THE ENHANCEMENT GROUP. IN CONCLUSION, APODIZED DIFFRACTIVE IOL IMPLANTATION AND EXCIMER LASER ENHANCEMENT IN EYES WITH PREVIOUS MYOPIC LASIK PROVIDED GOOD RESULTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE IOL MODEL THAT WAS IMPLANTED IN 11 EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83673 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./ HUNTINGTON SA60D3 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention