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

Catalog Number 8065740970

Device Problem Defective Device (2588)

Patient Problem Rupture (2208)

Event Date 12/05/2022

Event Type  Injury  

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 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.

Manufacturer Narrative

A sample has been received by manufacturing that has not yet been evaluated.The manufacturer internal reference number is: (b)(4).

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
• Type of Device: 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
• MDR Text Key: 306879796
• Report Number: 2523835-2023-00013
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657409709
• UDI-Public: 00380657409709
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065740970
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 01/20/2023; 04/24/2023
• Supplement Dates FDA Received: 02/13/2023; 05/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INFINITI VISION SYSTEM; IRRIGATION ASPIRATION TIP
• Patient Outcome(s): Other