MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE CENTURION VISION SYSTEM, HANDPIECE TIP; UNIT, PHACOFRAGMENTATION

Catalog Number	8065752066
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
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 the tip came off even after tightening when attaching to the ultrasound (us) handpiece during a test.The surgery completed with the replacement of another product.There was no report of patient harm.
Additional Manufacturer Narrative
One opened phaco tip in a wrench, in a box with tyvek label, was received for the report.The phaco tip was visually inspected and found conforming.The threads were functionally checked, and the threads were deemed to be conforming.There was wear on the back of the flange, thread area and nut corners consistent with threading on a handpiece.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 complaint evaluation could not confirm the reported complaint, the phaco tip was visually conforming and the thread check was performed and was also found to be conforming.The root cause cannot be determined from this evaluation as the threads were conforming.No action was taken as the phaco tip was manufactured to specifications.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.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: CENTURION VISION SYSTEM, HANDPIECE TIP
• Common Device Name: UNIT, PHACOFRAGMENTATION
• 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: 17342203
• Report Number: 2523835-2023-00373
• Device Sequence Number: 6548452
• Product Code: HQC
• UDI-Device Identifier: 00380657520664
• UDI-Public: 00380657520664
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121555
• 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): 10/23/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065752066
• Device Lot Number: 147LTT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE
• Patient Sex: Unknown