MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION FRAGMENTATION PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065750958
Medical Device Problem Codes	Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
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 frag was not able to break up the cataract efficiently during surgery.The patient experienced the event nucleus dropping posteriorly.The current outcome of the patient was unknown.This is first of four reports for this issue and represents the ophthalmic probe.
Additional Manufacturer Narrative
The event platform and code were updated.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
One opened phaco tip without a wrench, in a bag was received.Sample was visually inspected and found to be conforming.A functional test was performed on the threads and was found to be conforming to specifications.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 phaco tip not able to break up the cataract efficiently, nucleus dropping posteriorly as described in the complaint was not 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: CONSTELLATION FRAGMENTATION 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: 17841663
• Report Number: 1644019-2023-01315
• Device Sequence Number: 20626321
• Product Code: LRO
• UDI-Device Identifier: 00380657509584
• UDI-Public: 00380657509584
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: 8065750958
• Device Lot Number: 14RCJE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/03/2023
• Supplement Date Received by Manufacturer: 09/26/2023; 12/10/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 10/19/2023; 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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: CONSTELLATION SURGICAL PROCEDURE PACK; CONSTELLATION VISION SYS, ACC, FRAGMENTATION HP; CONSTELLATION VISION SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown