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

Catalog Number	8065750853
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that during a cataract surgery a patient experienced corneal burn and the wound was stitched.The surgery was completed on the same day and the patient condition is stable.This is one of three reports for this issue and represents the phacoemulsification handpiece.
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 phaco tip without a wrench, in a plastic container was received.Sample was visually inspected and found to be conforming.Wear observed on threads, back of flange, and nut corners consistent with threading on handpiece.Functional flow test was performed for occlusion and found to be conforming, good flow was observed exiting the tip and nothing extracted on the filter paper.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 phaco tip was found to be visually and functionally conforming therefore; a corneal burn, which caused a stitch needed in the cornea as described in the complaint could not be confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the phaco tip was functionally conforming.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: 18109034
• Report Number: 2523835-2023-00628
• Device Sequence Number: 7633741
• Product Code: HQC
• UDI-Device Identifier: 00380657508532
• UDI-Public: 00380657508532
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065750853
• Device Lot Number: 15AYDU
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• 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: CONSTELLATION SURGICAL PROCEDURE PACK; CUSTOM-PAK SURGICAL PROCEDURE PACK; HAND PIECE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown