MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE ALCON CLOSURE SYSTEM (ACS), NYLON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Catalog Number 8065198001

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

A nurse reported that before an ophthalmic surgery, the ophthalmic suture's needle form two different lot was found to be blunt.Procedure details and patient impact were not reported.Additional information received upon further follow-up stating that the scheduled surgery was trabeculectomy.Procedure was completed by using alternative ophthalmic suture from different packet.The needles were discarded after the operation.This report pertains to first of the two ophthalmic suture's needle involved in this reported event.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of blunt suture needle; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The photo attached to the parent file was reviewed by the manufacturing site.The photo show a label with reported lot number.Reported issue cannot be confirmed from photo.Because a sample was not received and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, the root cause for customer complaint issue cannot be determined.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.However, an investigation have been completed in relation to the related non-conformances identified within the non-conformance review suture material samples are tested at incoming for tensile strength and diameter and visually inspected for any defects such as discoloration and frays.Sutures are also 100% inspected by trained operators for discoloration and frays and for proper attachment during the manufacturing process.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

Event Description

A nurse reported that before an ophthalmic surgery, the ophthalmic suture's needle form two different lot was found to be blunt.Procedure details and patient impact were not reported.Additional information received upon further follow-up stating that the scheduled surgery was trabeculectomy.Procedure was completed by using alternative ophthalmic suture from different packet.The needles were discarded after the operation.

• Brand Name: ALCON CLOSURE SYSTEM (ACS), NYLON
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18864110
• MDR Text Key: 337228516
• Report Number: 2523835-2024-00287
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 00380651980013
• UDI-Public: 00380651980013
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K930517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065198001
• Device Lot Number: 154EDX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1