MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE SINGLE PIECE ULTRAFLOW SERIES; CATHETER, IRRIGATION

Catalog Number	8065817001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 customer reported that an ophthalmic irrigation/aspiration tip was broken.Procedure details were not provided.No impact to the patient.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in sections h.6 and h.10.The tip was not returned for evaluation.Specific product identifiers (lot number, batch number, and/or serial number) were not provided and could not be determined at this time.However, all device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.A review for complaints reported against this lot/batch/serial number cannot be performed as the lot/batch/serial number is unknown.The lot/batch/serial is unknown; therefore, a service history review cannot be performed.The root cause of the reported event is inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: SINGLE PIECE ULTRAFLOW SERIES
• Common Device Name: CATHETER, IRRIGATION
• 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: 14796458
• Report Number: 2523835-2022-00232
• Device Sequence Number: 14663436
• Product Code: GBX
• UDI-Device Identifier: 00380658170011
• UDI-Public: 00380658170011
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K910245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2022
• 2 Devices were Involved in the Event: 1 2

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: 8065817001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 07/20/2022; 09/07/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 08/18/2022; 10/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ULTRAFLOW II I/A HANDPIECE
• Patient Sex: Unknown