MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE IRRIGATION ASPIRATION TIP; CATHETER, IRRIGATION

Catalog Number	8065740970
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
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 capsular rupture and burr on the ophthalmic tip was observed.The surgery was completed.Additional information has been requested.
Additional Manufacturer Narrative
A sample has been received by manufacturing that has not yet been evaluated.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
There were no products returned for this investigation.Specific product identifiers (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.No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.A review for complaints reported against this serial number cannot be performed as the serial number is unknown.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.A root cause cannot be determined conclusively.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.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: IRRIGATION ASPIRATION TIP
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16119947
• Report Number: 2523835-2023-00013
• Device Sequence Number: 12900970
• Product Code: HQC
• UDI-Device Identifier: 00380657409709
• UDI-Public: 00380657409709
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112425
• 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,Followup
• Report Date (Section B): 05/19/2023
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065740970
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 01/20/2023; 04/24/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 02/13/2023; 05/19/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INFINITI VISION SYSTEM; IRRIGATION ASPIRATION TIP
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown