MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS; DEVICE, IRRIGATION, OCULAR SURGERY

Catalog Number	8065751512
Medical Device Problem Codes	Suction Problem (2170); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that the aspiration was not applied at all during use of irrigation aspiration tip from the beginning of the surgery, that the threaded part of the irrigation aspiration handpiece connection of the polymer irrigation aspiration tip was damaged.The surgery was completed after replacing the tip with another one.There's no patient harm.
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
One opened polymer irrigation/aspiration (i/a) tip was returned for the reported issue of aspiration failure and damaged threaded tip.The returned sample was visually inspected and was found to be nonconforming with the over molded threads observed to have some of the threads broken off.Functional test for thread check and occlusion/leakage could not be performed due to the visual non-conformance.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 returned non-conforming sample was received opened.How and when the i/a tip became damaged cannot be determined from this evaluation; therefore a root cause cannot be determined for the complaint as described by the customer.Due to the damage functional testing for aspiration could not be performed; therefore a root cause cannot be determined for the complaint as described by the customer.The exact root cause for the damage to the threads is unknown, therefore, specific action with regards to this complaint cannot be taken.All i/a tips are 100% visually inspected prior to being released from the manufacturing facility.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: DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS
• Common Device Name: DEVICE, IRRIGATION, OCULAR SURGERY
• 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: 18968327
• Report Number: 2523835-2024-00436
• Device Sequence Number: 20372165
• Product Code: KYG
• UDI-Device Identifier: 00380657515127
• UDI-Public: (01)00380657515127(17)250531(11)230622(10)15V356(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 08/07/2024

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 Expiration Date: 05/31/2025
• Device Catalogue Number: 8065751512
• Device Lot Number: 15V356
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• 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 Sex: Unknown