MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CENTURION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065752193
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	07/03/2023
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 customer reported that during a cataract surgery patient experienced burn on the main incision and surgical stitches were needed to close the incision.Additional information has been requested.
Additional Manufacturer Narrative
One 0.9mm ultra infusion sleeve without bubble suppression insert (bsi) was visually inspected and a pierced hole was found at the center of the infusion sleeve shaft.The damage was not made by a sharp edge rather exhibited signs of a puncture and tear.The tear is consistent with damage that occurs as a result of the phaco tip inadvertently piercing through the infusion sleeve during attaching to the handpiece.This error will cause a tear in the infusion sleeve which can potentially be attributed to surgical technique.Corneal burn is an issue that is occasionally reported with cataract surgery.Most corneal burns can be traced to issues related to surgical technique and not to malfunctioning equipment.Based on the information and sample obtained, the root cause is related to surgical technique, the infusion sleeve showed signs that infusion sleeve was damaged when mounted onto the phaco tip.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Current tracking indicates no adverse trend for this lot for this event.Similar incident/event data was collected for the associated reported events.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION SURGICAL PROCEDURE PAK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17304328
• Report Number: 1644019-2023-00872
• Device Sequence Number: 15257271
• Product Code: LRO
• UDI-Device Identifier: 00380657521937
• UDI-Public: 00380657521937
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/03/2023

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 Expiration Date: 12/31/2024
• Device Catalogue Number: 8065752193
• Device Lot Number: 159PN5
• 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: 07/03/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown