MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE; SUTURE, NONABSORBABLE

Device Problem Insufficient Information (3190)

Patient Problems Blurred Vision (2137); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The events were reported through a journal article and it is unknown if the events have been previously reported.No product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.

Event Description

It was reported in a journal article entitled: intraoperative performance and postoperative outcomes of endocapsular ring implantation in pediatric eyes authors: vaishali vasavada, ms, viraj a.Vasavada, ms, robert o.Hoffman, md, terrence s.Spencer, md, rishi v.Kumar, md, alan s.Crandall, md.Citation: j cataract refract surg.2008; 34: 1499¿1508.The purpose was to study the intraoperative performance and post-operative outcomes of cionni modified capsule tension ring (ctr) and intraocular lens (iol).A total of 22 patients (35 eyes; age range: 2.5 to o 18 years old) with ectopia lentis and visually significant cataract that had lens aspiration and in-the-bag implantation of single-piece acrysof iol and cionni ctr were included.Single- and double-eyelet ctrs were used.During the procedure, a prolene 9-0 or 10-0 double-armed suture on ctc needles was threaded through the fixation eyelets of the modified ctr.The 2 needles were passed into the main incision and then out through the ciliary sulcus and scleral wall, exiting beneath the scleral groove.Subsequently, the ctr was introduced through the main incision into the capsular bag and dialed into position so that the fixation eyelets lay in the area of maximum zonular weakness, thus ensuring that the eyelet or eyelets were positioned anterior to the capsulorhexis.The sutures were tightened and tied to center and stabilize the capsular bag.The main and paracentesis incisions and the conjunctiva were sutured with vicryl 10-0 polyglactin (vicryl) sutures.Reported complications: patient 8 (4.6-year-old right eye; 5.3-year-old left eye) female patient with pco on both eyes which required pars plana vitrectomy,it was concluded that the implantation of the cionni ctr and single-piece acrysof iol in the capsular bag in pediatric eyes with subluxated lenses was safe and effective and led to a stable iol with few significant complications.No further information is available.

• Brand Name: PROLENE POLYPROPYLENE SUTURE
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7630405
• MDR Text Key: 112156495
• Report Number: 2210968-2018-73689
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention