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

Catalog Number	8065752144
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during surgery while using a handpiece, aspiration failure occurred at the time of irrigation and aspiration.The procedure was completed after replacing the product with another one.The type of procedure was not reported.There was no harm to the patient.
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 i/a handpiece was received for the report of aspiration failure occurred.The returned sample was visually inspected and deemed nonconforming.Foreign material was observed in the port hole of the i/a handpiece.The foreign material was sent for analysis.Particle analysis was performed using micro fourier transform infrared (ft-ir).The spectra and visual characteristics suggest the foreign material to be dried salts.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The returned sample was deemed nonconforming with foreign material inside the port hole of the i/a handpiece, which could be a contributing factor for the reported aspiration failure.Particle analysis found the foreign material to be dried salts.Dried salt is not a material that is used in the i/a handpiece manufacturing process or in the packaging process of the i/a handpiece.How and when the dried salt got inside the port cannot be determined from this evaluation, therefore a root cause could not be determined.The most likely root cause for the dried salts is surgical material during use.No specific action with regard to this complaint was taken because the root cause for the complaint issue cannot be determined from this evaluation.All disposable ia handpieces are 100% visually inspected prior to being released from the manufacturing facility.Any non-conformances found are removed from the lot and scrapped.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: 18343179
• Report Number: 2523835-2023-00718
• Device Sequence Number: 12863641
• Product Code: KYG
• UDI-Device Identifier: 00380657521449
• UDI-Public: 00380657521449
• 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): 03/19/2024

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: 8065752144
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CENTURION VISION SYSTEM (ACTIVE SENTRY)
• Patient Sex: Unknown