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	8065751510
Medical Device Problem Codes	Obstruction of Flow (2423); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
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).
Event or Problem Description
A physician reported that during cataract surgery aspiration failure occurred due to obstruction in an ophthalmic irrigation and aspiration tip.The surgery was completed with alternate tip on the same day and there was no patient harm.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.Upon further review, the fda device event code has suction failure - a141303 been retracted from the file, as this event does not pertain to the ophthalmic system.One opened polymer irrigation and aspiration tip was returned for the report of an aspiration issue due to an obstruction.The returned sample was visually inspected and was found to be non-conforming with threads observed to be broken.The hub ribs were twisted in a spiraling motion.No foreign material or obstruction was observed in tip port hole; however, procedural residue was observed at port hole and on cannula.A functional water flow check could not be performed due to the visual damage, occlusion water flow check could not be performed.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 irrigation and aspiration tip became damaged and broken cannot be determined from this evaluation.Functional testing was unable to be performed due to the condition of the returned sample; therefore, a root cause cannot be determined for the reported occlusion issue as described by the customer.The most likely root cause for the damaged and broken tip is handling when placing the tip onto the handpiece.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All irrigation and aspiration 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: 21404348
• Report Number: 2523835-2025-00135
• Device Sequence Number: 9518895
• Product Code: KYG
• UDI-Device Identifier: 00380657515103
• UDI-Public: (01)00380657515103(17)260228(11)240322(10)16N4R0
• 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): 07/11/2025

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 8065751510
• Device Lot Number: 16N4R0
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• 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
• Patient Sex: Unknown