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

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

Patient Problems Cyst(s) (1800); Intraocular Pressure Increased (1937)

Event Date 06/21/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.H6 component code: g07002 ¿ device not returned the single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2023-10064 and 2210968-2023-10066.Citation: bmj publishing group limited 2023.Https://doi.Org/10.1136/bcr-2022-254240.

Event Description

Title: outcome of combined single-loop fixation of intraocular lens with ahmed glaucoma valve implantation.The aim of this study is to highlights the outcomes of single-loop fixation of iol (intraocular lens ) with agv in a post-traumatic setting and subsequent management of complications.Included in this study is a girl in late adolescence came with complaints of diminution of vision, photophobia and pain in the right eye for the past 2 months following a fire-cracker injury.Corneal traction suture was applied using 6-0 mersilk.The eyelets of the plates were fixed to the episclera using 8-0 nylon ethilon and the scleral flap was then repositioned using 6-0 polyglactin 910 vicryl and the conjunctiva was sutured using 8-0 polyglactin suture.Reported complications: increased intra ocular pressure (n-1).Tenon cyst(n-1).Conclusion: the combined approached of single- loop fixation of pciol with agv implantation is an effective procedure for rehabilitation of post traumatic open glaucoma with 180 degrees inferior capsular rim remnants and extensive conjunctival scarring.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18382672
• MDR Text Key: 331184658
• Report Number: 2210968-2023-10065
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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