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

Catalog Number	8065000133
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that during cataract surgery, the phacoemulsification handpiece and balance tip failed to irrigate, causing an error message and resulting in a wound burn in the patient's right eye.The wound was sutured, and the surgeon has also confirmed hearing occlusion bells.On post-operative day 3, an eye examination revealed corneal edema and minimal induced astigmatism due to the suturing and wound burn.The patient's condition is improving.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation.Therefore, the condition of the product could not be verified.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 images was attached to the file was reviewed by the manufacturing site.Images show a handpiece and a tray with reported lot number.Reported issue cannot be confirmed from images.A sample was not received at the manufacturing site and the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.The cause of the reported event cannot be determined with the information obtained, therefore, specific action with regards to this complaint cannot be taken.All phacoemulsification 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 additional action is required at this time.The manufacturer internal reference number is: (b)(4).H10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A customer reported that during cataract surgery, the phacoemulsification handpiece and balance tip failed to irrigate, causing an error message and resulting in a wound burn in the patient's right eye and it was caused phaco handpiece overheating.The wound was sutured, and the surgeon has also confirmed hearing occlusion bells.On post-operative day 3, an eye examination revealed corneal edema and minimal induced astigmatism due to the suturing and wound burn.The patient's condition is improving.
Additional Manufacturer Narrative
Corrected information was updated in d.4.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported that during cataract surgery, the phacoemulsification handpiece and balance tip failed to irrigate, causing an error message and resulting in a wound burn in the patient's right eye and it was caused phaco handpiece overheating.The wound was sutured, and the surgeon has also confirmed hearing occlusion bells.On post-operative day 3, an eye examination revealed corneal edema and minimal induced astigmatism due to the suturing and wound burn.The patient's condition is improving.

• 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: 19657254
• Report Number: 1644019-2024-01416
• Device Sequence Number: 6624474
• Product Code: LRO
• UDI-Device Identifier: 00380650001337
• UDI-Public: (01)00380650001337(17)260331(11)240428(10)16RAK3(21)NA
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: 8065000133
• Device Lot Number: 16RAK3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 09/11/2024; 10/10/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 10/10/2024; 11/08/2024
• Date Device Manufactured: 04/28/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 73 KG