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

Device Problem Insufficient Information (3190)

Patient Problem Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Citation: j cataract refract surg.2010; 36: 373¿376, (b)(4).

Event Description

It was reported via journal article: "title: scleral fixation of intraocular lenses combined with penetrating keratoplasty" authors: fahad a.Al-qahtani, md 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.

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7643346
• MDR Text Key: 112549544
• Report Number: 2210968-2018-73894
• 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
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2018

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention