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

Catalog Number	8065304901
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/23/2021
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A physician reported that a suture was used for the intra-ocular lens (iol) implantation of a cataract surgery.On the post-operative day one review, the physician noticed that the iol dropped to posterior chamber and the suture was torn.The patient underwent additional surgery to fix it with the suture, however suture was torn during the surgery.The surgery was completed successfully by replacing the suture with another one.
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.A review of the device history record (dhr) traceable to the reported lot number indicates that the reported product was processed and released according to the reported product¿s acceptance criteria because a sample was not received and the dhr 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.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.No adverse trends have been observed associated with the reported product and event.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ALCON CLOSURE SYSTEM (ACS), PAIR PAK, POLYPROPYLENE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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: 13026730
• Report Number: 2523835-2021-00484
• Device Sequence Number: 17503410
• Product Code: GAW
• UDI-Device Identifier: 00380653049015
• UDI-Public: 00380653049015
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P890002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: 8065304901
• Device Lot Number: 13PM5D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown