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

Catalog Number	8065198001
Medical Device Problem Codes	Break (1069); Material Discolored (1170)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2025
Type of Reportable Event	Malfunction
Additional 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A healthcare professional reported that a suture was found to be fragile and breaks continuously and also, they appeared to be darker than usual.The scheduled surgery was found to be intraocular lens implantation.Patient impact was not reported.
Additional Manufacturer Narrative
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 or Problem Description
Additional information received stating that the surgery was completed on the same day using another suture with no impact on patient.
Additional Manufacturer Narrative
Six unopened sutures in blisters within pouches were received for the report fragile, breaks continuously., and is darker than usual.The returned unopened samples were visually inspected, and all samples were found non-conforming for suture color, suture was lighter in color.The suture was visually conforming for breakage.The returned samples were then dimensional inspected for suture diameter and functionally tested for suture tensile strength and all samples were found to be conforming.Because the sutures were noted to be lighter in color, a second visual inspection took place.The channels of the needles were opened; the samples were visually inspected and was found to be conforming for black suture color inside of the channels.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 investigation conducted a non-conformance review of the reported [lot/batch/serial] number.No deviations, were identified and all corresponding production release specifications defined in the device master record were met.Based on the evaluation of the information and materials received, the investigation concluded that the root cause of the reported event is not determined as the returned sample was conforming for all dimensional, and functional testing for the reported issue of the suture was fragile and continuously broke.The evaluation confirms the suture was the wrong color however it was lighter in color not darker in color.Therefore, a transparent suture as described in the complaint was confirmed; however, since the suture color within the channel was confirmed as black; a root cause cannot be determined for the complaint as described by the customer.Based on the evaluation of the information and materials received, the investigation was unable to identify the root cause or origin of the reported event.Additionally, no manufacturing-related deficiencies were found that potentially could have contributed to the complaint.The evaluation confirms the suture was the wrong color however it was lighter in color not darker in color.Therefore, a transparent suture as described in the complaint was confirmed; however, since the suture color within the channel was confirmed as black; a root cause cannot be determined for the complaint as described by the customer.The returned sample was conforming for all dimensional, and functional testing for the reported issue of the suture was fragile and continuously broke.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time for the color issue.The returned samples met specification dimensionally and functionally for suture breakage.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.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.While the root cause and its origin are inconclusive for the suture color, a possible root cause for the suture color being lighter is that it was exposed a hydrogen peroxide-based cleaner which can permeate the tyvek packaging material when sprayed in close proximity.The hydrogen peroxide will discolor the suture material.Complaint data for all manufacturer products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action warranted at this time.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.

• Brand Name: ALCON CLOSURE SYSTEM (ACS), NYLON
• Common Device Name: 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: 22061809
• Report Number: 2523835-2025-00603
• Device Sequence Number: 20795760
• Product Code: GAR
• UDI-Device Identifier: 00380651980013
• UDI-Public: (01)00380651980013(17)290731(11)240822(10)1714D5
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K930517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 8065198001
• Device Lot Number: 1714D5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 05/22/2025; 10/09/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/17/2025; 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALCON CLOSURE SYSTEM (ACS), NYLON.
• Patient Sex: Unknown