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

Catalog Number	8065752203
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
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 physician reported ultrasound tip was cracked and broke inside the patient's eye during surgery.The damaged tip was taken out of the eye along with the sleeve and did not fall into the patient eye.It was not reported if the surgery was completed after replacing the product with another one.There was no patient harm.The procedure details was unknown.Additional information was received from surgeon that there was no effect observed on the patient, as the tip was immediately noticed to be damaged and removed from the eye.There was no strong inflammation observed the day after surgery, and no particular health problems were observed.
Additional Manufacturer Narrative
One opened broken phaco tip without a wrench with a sleeve in a bag and two unopened phaco trays were received for the report.The opened phaco tip was visually inspected and deemed nonconforming, the phaco tip was broken at the balanced tip bend area with a slightly jagged edge.The phaco had even wall thickness.There was wear on the threads, back of flange and nut corners that was consistent with threading on a handpiece.The two unopened phaco tips were visually inspected and found to be conforming.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 confirms the phaco tip was broken.The root cause for the broken phaco tip cannot be determined from this evaluation.The phaco tip visual inspection does not show any manufacturing issue that would cause the broken phaco tip.A complaint trend has been identified for broken phaco¿ s therefore an investigation has been opened.The complaint evaluation does not confirm the phaco tips are broken/cracked on the unopened samples, therefore the root cause for broken tip cannot be determined from this evaluation.The exact root cause for the broken phaco tip is unknown; therefore, specific action with regards to this complaint cannot be taken.An investigation is currently in progress, in order to further investigate issues with the phaco tip.No actions were taken on the unopened samples as the phaco tips were manufactured to specification.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Any nonconformance, such as the broken phaco tip exhibited on the returned opened sample, is removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.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: 16446274
• Report Number: 1644019-2023-00179
• Device Sequence Number: 14921749
• Product Code: LRO
• UDI-Device Identifier: 00380657522033
• UDI-Public: 00380657522033
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 8065752203
• Device Lot Number: 14CYX1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• 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.
• Patient Age: 88 YR
• Patient Sex: Female