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

Catalog Number	8065215201
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A government agency reported that an ophthalmic surgical suture needle was broken during left eyelid ectropion correction, flap repair, and inner and outer canthoplasty surgery.The patient underwent computed tomography (ct) 7 for orbital plain scan and three-dimensional (3d) reconstruction.It was found that the broken suture needled was still in the patient's eye.The other procedure details and patient impact were not reported.
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).
Additional Manufacturer Narrative
Additional information was provided in sections h.6., and h.11.A sample was not received at the manufacturing site for evaluation for the report of suture needle broken during use; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information was provided; therefore, the root cause for the customer complaint issue cannot be determined.The cause of the reported event cannot be determined with the information obtained; therefore, specific action with regards to this complaint cannot be taken.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: ALCON CLOSURE SYSTEM (ACS), POLYESTER
• Common Device Name: SUTURE, NONABSORBABLE, POLYESTER
• 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: 19769590
• Report Number: 2523835-2024-01749
• Device Sequence Number: 12956258
• Product Code: GAS
• UDI-Device Identifier: 00380652152013
• UDI-Public: 00380652152013
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P880094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 8065215201
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2024
• Supplement Date Received by Manufacturer: 09/22/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 10/18/2024
• 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
• Patient Age: 57 YR
• Patient Sex: Male