MAUDE Adverse Event Report: ETHICON INC. NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, SYNTHETIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

(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.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? web address: http://dx.Doi.Org/10.1016/j.Jcrs.2013.05.014 citation: j cataract refract surg 2013; 39:979¿983.(b)(4).

Event Description

It was reported via journal article title : transscleral suturing of the implantable miniature telescope.Author : marjan farid, md.Web address: http://dx.Doi.Org/10.1016/j.Jcrs.2013.05.014.Citation: j cataract refract surg 2013; 39:979¿983.The author described a technique for transscleral suturing of the implantable miniature telescope device for end-stage age-related macular degeneration (amd).It provides stabilization and centration of the implantable miniature telescope device in the case of capsule rupture or severe zonular dialysis.An (b)(6) woman with end-stage amd was deemed a good candidate for the implantable miniature telescope after preoperative evaluation by retinal, low-vision, and corneal specialists.After successful phacoemulsification of the cataract in her left eye, a 180-degree temporal conjunctival peritomy was performed.An ab interno technique of transscleral fixation was used to secure the device.A double-armed prolene 9-0 suture on a ctc-6 needle was thrown through the eyelet of the haptic and exited through the sclera at the level of the ciliary sulcus, approximately 2.0 mm posterior to the limbus.The second arm of the suture was similarly placed through the sclera at a point approximately 2.0 mm from the previous exit site.With an ab interno technique, a scleral flap can be made prior to passing the needle so the suture knot remains buried beneath the flap.Alternatively, the suture can be tied on the sclera with the suture ends left long and tucked to lie flat beneath conjunctiva, as was done in this case.The main wound was closed with nylon sutures and the conjunctiva was closed with vicryl 8-0 sutures.At 10-day examination post-operatively, reported complications included very mild corneal edema, significant debris and pigment cells coated the optic surface, and mild vitreous hemorrhage.At 1-year visit, the debris on the optic was completely clear and the implantable miniature telescope remained well positioned.It was concluded that this technique offers a safe and reliable method for securing the implantable miniature telescope device in cases of capsule disruption.

• Brand Name: NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• 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: 7661630
• MDR Text Key: 113162703
• Report Number: 2210968-2018-74072
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2018

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: 06/07/2018
• Initial Date FDA Received: 07/03/2018
• 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
• Patient Age: 80 YR