BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7635963 · Received June 25, 2018

    Report

    Report Number
    2210968-2018-73771
    Event Type
    Injury
    Date Received
    June 25, 2018
    Report Date
    June 5, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. (B)(4).

    Additional Manufacturer Narrative · 1

    PC-(B)(4). DATE SENT TO THE FDA: (B)(4) 2018. IT WAS REPORTED THAT THIS DEVICE IS NOT MALFUNCTION REPORTABLE. THEREFORE, THIS MEDWATCH REPORT 2210968-2018-73771 IS NOT REPORTABLE. ADDITIONAL INFORMATION RECEIVED: - WERE THE CASES PREVIOUSLY REPORTED TO ETHICON, IF SO, PLEASE PROVIDE THE REFERENCE NUMBER. NO; - DO YOU BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? NO; - DO YOU BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? NO

    Additional Manufacturer Narrative · 1

    PC-(B)(4). DATE SENT TO THE FDA: (B)(4) 2018. CORRECTED INFORMATION: ¿ SERIOUS INJURY. ¿COMPLICATIONS INCLUDED IOL DISLOCATION DUE TO SUTURE BREAKAGE (N=1) WHICH REQUIRED RE-SUTURING,¿ THIS MEDWATCH REPORT 2210968-2018-73771 IS REPORTABLE.

    Description of Event or Problem · 1

    TITLE: OUTCOMES OF SCLERAL-SUTURED CONVENTIONAL AND ANIRIDIA INTRAOCULAR LENS IMPLANTATION PERFORMED IN A (B)(4) HOSPITAL SETTING. THIS RETROSPECTIVE STUDY AIMED TO EVALUATE THE MEDIUM- TO LONG-TERM VISUAL OUTCOMES AND COMPLICATION RATES IN EYES THAT HAD TRANSSCLERAL-SUTURED POSTERIOR CHAMBER INTRAOCULAR LENS (PC IOL) IMPLANTATION AT A PUBLIC UNIVERSITY HOSPITAL. IN THE 17-YEAR PERIOD BETWEEN 1996 AND 2012, 78 PATIENTS/EYES (N=63 MALE AND N=15 FEMALE; MEAN AGE SD OF 41±21 YEARS) OF TRANSSCLERAL-SUTURED PC IOL IMPLANTATION WERE IDENTIFIED INDICATED FOR OCULAR TRAUMA (N=36), COMPLICATED CATARACT SURGERY (N=8), IDIOPATHIC IOL DISLOCATION (N=8), CONGENITAL CATARACT REMOVAL (N=8), MARFAN SYNDROME (N=7), IDIOPATHIC DISLOCATION OF CRYSTALLINE LENS (N=6), POST AC IOL REMOVAL (N=3), AND LENS DAMAGE DURING INTRAOCULAR SURGERY (N=2). DOUBLE-ARMED 10-0 PROLENE SUTURE AN A STRAIGHT NEEDLE WAS USED FIX THE IOL TO THE SCLERA USING A NO-TOUCH TECHNIQUE INVOLVING AVOIDANCE OF ANY INSTRUMENT CONTACT WITH THE SUTURE MATERIAL WITHIN 20.0MMOF WHERE THE KNOT IS TO BE TIED, ENSURING THE RESIDUAL SUTURE MATERIAL HAS NOT BEEN MANIPULATED OR COMPROMISED. COMPLICATIONS INCLUDED IOL DISLOCATION DUE TO SUTURE BREAKAGE (N=1) WHICH REQUIRED RE-SUTURING, AND PUPIL CAPTURE OF IOL (N=2) REQUIRING REPOSITIONING BY SIMPLE RETROPULSION. THE CASES OF PUPIL CAPTURE OF THE IOL WERE PRESUMED TO BE SECONDARY TO IOL TILT. THE EARLY POSTOPERATIVE CORNEAL EDEMA WAS MORE PREVALENT WHEN SCLERAL FIXATION IOL SURGERY IS PERFORMED AS A PRIMARY RATHER THAN A SECONDARY PROCEDURE AFTER COMPLICATED CATARACT SURGERY, POSSIBLY REFLECTING INTRAOCULAR MANIPULATION. THE CORNEAL WOUND LEAKAGE OCCURRED IN THE CONTEXT OF EXTENSIVE PRE-EXISTING CORNEAL INJURY. OCULAR HYPERTENSION IS A WELL-DOCUMENTED COMPLICATION AFTER SCLERAL-FIXATED IOL IMPLANTATION, BECAUSE OF THE RISK FACTORS OF OCULAR TRAUMA, A HISTORY OF GLAUCOMA, USE OF OVDS, HYPHEMA, AND CORTICOSTEROID USE. THE REPORTED POSTOPERATIVE OCULAR HYPERTENSION, GLAUCOMA AND GLAUCOMA REQUIRING SURGERY MAY BE RELATED TO THE IOL¿S SIZE. OF THE 5 POSTOPERATIVE RETINAL DETACHMENT, 4 HAD PREVIOUS DETACHMENT AND 1 HAD PREVIOUS TRAUMATIC GLOBE RUPTURE. THERE WERE NO CASES OF SUTURE EXPOSURE, KNOT EROSION, SUTURE ABSCESS, GRANULOMA, OR ENDOPHTHALMITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477024 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention