BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2947257 · Received January 30, 2013

    Report

    Report Number
    1119421-2013-00072
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    December 1, 2009
    Report Date
    December 31, 2012
    Manufacturer
    ALCON RESEARCH. LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SALEH M, BOURCIER T, SPEEG C, DELBOSC B, MONTARD M, GAUCHER D. SUTURELESS INTRASCLERAL INTRAOCULAR LENS IMPLANTATION AFTER OCULAR TRAUMA. JOURNAL OF CATARACT AND REFRACTIVE SURGERY. 2013; 39 (1): 81-86. (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE, AN OPHTHALMOLOGIST REPORTED THE RESULTS OF A RETROSPECTIVE CHART REVIEW IDENTIFYING PATIENTS WITH ACUTE TRAUMATIC CATARACT OR LENS DISLOCATION WHO HAD LENS EXTRACTION AFTER BLUNT TRAUMA. THE PURPOSE OF THIS ARTICLE WAS TO REPORT THE RESULTS AND SAFETY OF SUTURELESS INTRASCLERAL HAPTIC FIXATION IN TRAUMATIZED EYES AND TO COMPARE THIS PROCEDURE WITH RETROPUPILLARY IRIS-CLAW IOL FIXATION. ALL PATIENTS HAD A PARS PLANA VITRECTOMY COMBINED WITH INTRAOCULAR LENS (IOL) IMPLANT SURGERY. FOR THE INTRASCLERAL IOL GROUP, THERE WAS ONE PATIENT THAT HAD CONJUNCTIVAL EROSION DUE TO HAPTIC EXPOSURE, NECESSITATING THE RESECTION OF THE SCLERAL FLAP UNDER TOPICAL ANESTHESIA TO BURY THE HAPTIC. TWO OTHER PATIENTS DEVELOPED POSTOPERATIVE MACULAR EDEMA. ONE EYE RESPONDED WELL TO A THREE MONTH COURSE OF ORAL ACETAZOLAMIDE AND TOPICAL ANTI-INFLAMMATORY TREATMENT. THE SECOND EYE REQUIRED AN INTRAVITREAL CORTICOSTEROID INJECTION. A FOURTH EYE DEVELOPED UVEITIS. THE ARTICLE DID NOT PROVIDE ANY FURTHER INFORMATION FOR THIS PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS ARTICLE. THIS REPORT IS FOR THE FIRST PATIENT WITH MACULAR EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40202 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH. LTD./HUNTINGTON MN60AC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention VISCOAT| 23-GAUGE CATHETER NEEDLE| VICRYL SUTURES| 10-0 NYLON SUTURES