BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3207255 · Received July 2, 2013

    Report

    Report Number
    1119421-2013-00730
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 6, 2013
    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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE REPORT OF REVERSE OPTIC CAPTURE OF THE SINGLE-PIECE ACRYLIC IOL IN EYES WITH PC RUPTURE IS A FAILURE TO FOLLOW THE DFU FOR THE PRODUCT. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO. A COMPLETED QUESTIONNAIRE WAS NOT REC'D. JONES J, OETTING T, ROGERS G, JIN G. REVERSE OPTIC CAPTURE OF THE SINGLE-PIECE ACRYLIC LENS IN EYES WITH POSTERIOR CAPSULE RUPTURE. OPHTHALMIC SURGERY, LASER & IMAGING 2012, 43:480-488. (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE, THE AUTHORS PRESENTED THE RESULTS OF A RETROSPECTIVE RECORD REVIEW OF PTS WHO HAD REVERSE OPTIC CAPTURE (ROC) PERFORMED DURING PHACOEMULSIFICATION OR INTRAOCULAR LENS (IOL) SURGERY FROM NOVEMBER 2007 TO APRIL 2011. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE CLINICAL RESULTS OF ROC WITH SINGLE PIECE POSTERIOR CHAMBER IOLS IN CASES OF PHACOEMULSIFICATION CATARACT AND IOL SURGERY WITH POSTERIOR CAPSULAR RUPTURE (PCR). THE STUDY GROUP WAS COMPROMISED OF SIXTEEN EYES OF SIXTEEN PTS. A SINGLE PIECE ACRYLIC FOLDABLE MONOFOCAL IOL WAS USED IN THIS STUDY IN FIFTEEN EYES. ONE EYE REC'D A MULTIFOCAL LENS. THE CONTROL GROUP ALSO HAD SINGLE PIECE ACRYLIC FOLDABLE MONOFOCAL IOLS. THE AUTHORS FOUND THAT ALL ROCS WERE PERFORMED UNEVENTFULLY ON ALL EYES IN THE SERIES. NO COMPLICATIONS OCCURRED DURING THE PROCEDURE. THE INTRAOCULAR PRESSURE (IOP) WAS HIGHER THAN 25 MMHG (31% RANGE: 25 TO 24 MMHG) IN FIVE EYES IN THE ROC GROUP AND IN ONE EYE IN THE CONTROL GROUP. THESE PTS WERE TREATED WITH ORAL CARBONIC ANHYDRASE INHIBITORS, TOPICAL AQUEOUS SUPPRESSANTS, OR BOTH. IOP WAS RAPIDLY CONTROLLED AND BECAME NORMAL (LESS THAN 21 MMHG) W/O MEDICATION IN ALL PTS AT ONE WEEK F/U. THE AUTHORS REPORTED THAT NO EYE LOST MORE THAN ONE LINE BCVA IN EITHER GROUP POSTOPERATIVELY. THERE WERE NO SIGNIFICANT DIFFERENCES IN PREOPERATIVE AND POSTOPERATIVE LOG MAR BCVA BETWEEN THE GROUPS. AT THE FINAL VISIT, 94% OF THE EYES IN THE ROC GROUP AND 92% IN THE CONTROL GROUP HAD A BCVA OF 20/25 OR BETTER. THE AUTHORS REPORTED NO VISION THREATENING COMPLICATIONS, SUCH AS ENDOPHTHALMITIS, CYSTOID MACULAR EDEMA AND RETINAL DETACHMENT, IN THESE PTS IN THE F/U PERIOD. NO FURTHER SURGERY WAS NEED EXCEPT FOR YAG CAPSULOTOMY. THE AUTHORS REPORTED THIS STUDY HAS LIMITATIONS DUE TO ITS RETROSPECTIVE NATURE. THE CASE NUMBER IS SMALL EVEN AFTER JOINING THE DATA FROM TWO BUSY CENTERS BECAUSE THE INDICATION FOR THE USE OF THE ROC TECHNIQUE WAS SPECIFIC. THE F/U WAS RELATIVELY SHORT AND THE AUTHORS RECOGNIZED THAT SOME COMPLICATIONS SUCH AS IOL DECENTRATION, CAN OCCUR YRS AFTER SURGERY. THE RESULTS OF THE STUDY SUGGEST THAT ROC MERITS CONSIDERATION IN SELECTED CASES WITH PCR. THE RATES OF POSTOPERATIVE COMPLICATIONS WERE LOW, AND THERE WERE NO VISION THREATENING COMPLICATIONS THROUGHOUT THE F/U. FUTURE STUDIES WITH A LARGER NUMBER AND LONGER F/U WERE RECOMMENDED TO ASSESS THE LAST ONSET COMPLICATIONS AND MONITOR THE LONG TERM STABILITY OF THE IOLS. ADD'L INFO HAS BEEN REQUESTED. THIS REPORT IS BEING FILED FOR ALL LENS MODELS MENTION BY THE AUTHORS IN THIS ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302769 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention