BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3052941 · Received April 5, 2013

    Report

    Report Number
    1119421-2013-00363
    Event Type
    Injury
    Date Received
    April 5, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 11, 2013
    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
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFR DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. ADD'L INFO HAS BEEN REQUESTED. (B)(6) SURGICAL MANAGEMENT CHALLENGES AND CLINICAL RESULTS OF BIMANUAL MICRO-INCISION PHACOEMULSIFICATION CATARACT SURGERY IN CHILDREN WITH CONGENITAL CATARACT. NEPAL J OPHTHALMOL 2011 :3(5): 3-8. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE REPORT, THE AUTHORS DESCRIBED THE RESULTS OF A RETROSPECTIVE STUDY WHICH INVOLVED SMALL INCISIONS WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES IN CHILDREN WITH CONGENITAL CATARACTS. TWENTY TWO EYES OF FOURTEEN CHILDREN AGED FROM (B)(6) WITH CONGENITAL CATARACTS WERE INCLUDED IN THE STUDY. MICRO INCISION CATARACT SURGERY WITH LENSECTOMY, BIMANUAL ASPIRATION OR PHACOEMULSIFICATION AND IMPLANTATION OF AN IOL WAS PERFORMED UNDER GENERAL ANESTHESIA. THE AUTHOR REPORTED THAT AN ANTERIOR VITRECTOMY WAS PERFORMED AT THE TIME OF THE IOL IMPLANT IN FOURTEEN EYES ((B)(4)). SIX EYES REQUIRED A RADIAL SUTURE FOR TIGHT WOUND CLOSURE. IN ALL THE OTHER EYES, THE INCISION KEPT TIGHT AND REMAINED SUTURE-LESS. IN ALL OPERATED EYES, MICRO-INCISION CATARACT SURGERY COULD BE PERFORMED WITHOUT SERIOUS INTRAOPERATIVE COMPLICATIONS. LENSECTOMY WAS SAFELY COMBINED WITH A PRIMARY POSTERIOR CAPSULORHEXIS AND ANTERIOR VITRECTOMY IN SEVENTEEN OF TWENTY TWO EYES. CORNEAL INCISION LENGTH RANGED BETWEEN 2.2 MM AND 2.6MM. NO CASES OF POSTOPERATIVE HYPOTONY OR INCREASED INFLAMMATION WERE OBSERVED. NO SEVERE COMPLICATION WERE OBSERVED IN ANY OF THE STUDY EYES DURING FOLLOW UP. AT SEVEN MONTHS POSTOPERATIVE, ONE EYE WAS OBSERVED TO HAVE PRIMARY FIBROSIS THAT HAD INCREASED AND OBSCURED THE VISUAL AXIS. FOR THIS REASON, THE AFTER CATARACT WAS REMOVED IN A SECONDARY SURGICAL PROCEDURE. LASER CAPSULOTOMY FOR POSTERIOR CAPSULE OPACIFICATION (PCO) HAD TO BE PERFORMED IN TWO ((B)(4)) EYES. IN ALL OTHER EYES ((B)(4)), VISUAL AXIS REMAINED CLEAR DURING FOLLOW-UP. THE AUTHOR REPORTED THAT CONSIDERING THE PRESENCE OF AMBLYOPIA AT THE BEGINNING OF POSTOPERATIVE OCCLUSION TREATMENT, VISUAL DEVELOPMENT WAS GENERALLY SATISFYING IN MOST PATIENTS. HOWEVER, EYES WITH UNILATERAL CATARACTS HAD A GENERALLY WORSE VISUAL ACUITY POSTOPERATIVELY WHEN COMPARED TO BILATERAL CATARACT PTS. IN CONCLUSION, THE AUTHOR STATED MICRO-INCISION CATARACT SURGERY IS A PROMISING ALTERNATIVE TO CONVENTIONAL PEDIATRIC CATARACT SURGERY, SINCE THE TECHNIQUE SHOWED TO BE COMPARABLY SAFE AND EFFECTIVE. THE AUTHOR RECOMMENDED FURTHER STUDIES AND LONGER FOLLOW-UP EXAMINATIONS IN THE FUTURE. ADD¿L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139786 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./ HUNTINGTON SN60WF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention