MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE INTREPID COAXIAL POLYMER CONICAL DISPOSABLE I/A HANDPIECE; DEVICE, IRRIGATION, OCULAR SURGERY

Catalog Number	8065752145
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that ophthalmic irrigation and aspiration was clogged.Patient and procedure were not reported.No patient harm was 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.A sample is available that has not yet been received at manufacturing for evaluation.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
One opened polymer i/a coaxial was received for the report of occlusion.The returned sample was visually inspected and found conforming.An occlusion/leakage test was performed on the handpiece and was found conforming.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 sample was found to be visually and functionally conforming; therefore the root cause for the customer complaint issue cannot be determined.The sample was found to meet specification all handpieces 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 further actions are required.The manufacturer internal reference number is:(b)(4).

• Brand Name: INTREPID COAXIAL POLYMER CONICAL DISPOSABLE I/A HANDPIECE
• 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: 19329307
• Report Number: 2523835-2024-00995
• Device Sequence Number: 14222150
• Product Code: KYG
• UDI-Device Identifier: 00380657521456
• UDI-Public: 00380657521456
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: 11/30/2024
• Device Catalogue Number: 8065752145
• Device Lot Number: 157618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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