BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7641432 · Received June 27, 2018

    Report

    Report Number
    2210968-2018-73876
    Event Type
    Injury
    Date Received
    June 27, 2018
    Report Date
    June 4, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. . IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: J CATARACT REFRACT SURG. 2010; 36: 373¿376. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: SCLERAL FIXATION OF INTRAOCULAR LENSES COMBINED WITH PENETRATING KERATOPLASTY AUTHOR: FAHAD A. AL-QAHTANI, MD WEB ADDRESS: DOI:10.1016/J.JCRS.2009.09.041 CITATION: J CATARACT REFRACT SURG. 2010; 36: 373¿376 DOI: 10.1016/J.JCRS.2009.09.041. THE PURPOSE OF THIS STUDY WAS TO DESCRIBE A TECHNIQUE FOR TRANSSCLERAL FIXATION OF A POSTERIOR CHAMBER INTRAOCULAR LENS (PC IOL) COMBINED WITH PENETRATING KERATOPLASTY (PKP). A TOTAL OF 5 EYES OF 5 PATIENTS WITH APHAKIC BULLOUS KERATOPATHY AND LACK OF POSTERIOR CAPSULE SUPPORT WHO HAD PKP BETWEEN DECEMBER 2004 AND SEPTEMBER 2007 WERE INCLUDED IN THE STUDY. DURING THE SURGICAL PROCEDURE, A DOUBLE-ARMED PROLENE 10-0 SUTURE ON STRAIGHT NEEDLES IS CUT IN HALF. THE SUTURE END OF EACH HALF IS TIED TO THE HAPTICS OF AN IOL. ALTHOUGH IT REQUIRES A LARGER INCISION, A RIGID PMMA IOL MIGHT CAUSE LESS TRAUMA AT THE GRAFT¿HOST INTERFACE DURING INSERTION THAN A FOLDED IOL. ONE STRAIGHT NEEDLE IS PASSED THROUGH THE SUPERIOR CORNEAL INCISION WITH THE SUTURE END EXITING THROUGH THE INFERIOR CORNEAL INCISION. THE NEEDLE IS THEN PASSED THROUGH THE INFERIOR CORNEAL INCISION BEHIND THE IRIS, EXITING INTO THE SUPERIOR SCLERAL BED 1.5 MM FROM THE LIMBUS. THE OTHER NEEDLE IS PASSED DIRECTLY FROM THE SUPERIOR CORNEAL INCISION, EXITING THROUGH THE INFERIOR SCLERAL BED. THE SUTURES ARE PULLED TIGHTLY AND TEMPORARILY TIED UNDER THE SCLERAL FLAPS. AFTER STABLE IOL CENTRATION IS ACHIEVED, A SURGEON¿S KNOT IS COMPLETED. THE SCLERAL FLAP IS THEN REPLACED TO COVER THE POLYPROPYLENE KNOT WITH A VICRYL 8-0 SUTURE AND THE OVERLYING CONJUNCTIVA WAS RE-APPROXIMATED WITH THE SAME SUTURE MATERIAL. REPORTED COMPLICATIONS INCLUDED PATIENT 1 WITH CORNEAL ULCER WHICH WAS TREATED WITH LUBRICANTS AND TOPICAL ANTIBIOTIC AGENTS; THE ULCER RESOLVED IN 5 DAYS; PATIENT 2 WITH HYPHEMA THAT DEVELOPED DURING SCLERAL PASSES OF THE SUTURES WHICH REQUIRED INJECTION OF OVD, VITREOUS PROLAPSE WHICH REQUIRED ANTERIOR VITRECTOMY BEFORE IOL, AND GLAUCOMA WHICH REQUIRED SINGLE ANTI GLAUCOMA MEDICATION; PATIENT 3 WITH ANGIOGRAPHIC CYSTOID MACULAR EDEMA; AND PATIENT 5 WITH HYPHEMA DURING SYNECHIOLYSIS WHICH REQUIRED INJECTION OF OVD AND GLAUCOMA WHICH REQUIRED SINGLE ANTI GLAUCOMA MEDICATION. THE AUTHOR BELIEVED THAT THE SURGICAL TECHNIQUE DESCRIBED IS SAFE AND REPRODUCIBLE AND SHOULD BE CONSIDERED AS AN OPTION IN APHAKIC EYES THAT LACK CAPSULE SUPPORT AND REQUIRE KERATOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483659 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VICRYL SUTURE