MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON UNITY INFUSION CANNULA; UNIT, PHACOFRAGMENTATION

Catalog Number	8065000468
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Endophthalmitis (1835)
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that the surgeon did observe that the infusion cannula was not sealing on the cannula during the case and patient developed a postoperative day 3 (pod3) endophthalmitis after surgery which was confirmed with a vitrectomy tap and successfully treated with antibiotics.The procedure details were unknown.
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
No product has been returned the investigation site for evaluation; therefore, the condition of the product could not be verified.All product is delivered to our customers in a sterile manner.An evaluation is conducted during manufacturing to ensure each requested item meets customer, process, and regulatory requirements.Receipt of complaint product or additional information pertinent to this complaint will result in re-evaluation of the complaint investigation.The investigation conducted a non-conformance review of the reported lot number.No deviations, were identified and all corresponding production release specifications defined in the device master record were met.The root cause of the customer's complaint could not be conclusively determined as product was not returned and the condition of the product could not be verified.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.As described, all unity product is delivered to our customers in a sterile manner.An evaluation is conducted during manufacturing to ensure each requested item meets customer, process, and regulatory requirements.Complaint data for all alcon products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action warranted at this time.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.

• Brand Name: UNITY INFUSION CANNULA
• Common Device Name: UNIT, PHACOFRAGMENTATION
• 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: 21721556
• Report Number: 1644019-2025-00866
• Device Sequence Number: 21205394
• Product Code: HQC
• UDI-Device Identifier: 00380650004680
• UDI-Public: (01)00380650004680(17)260831(11)240926(10)172EJL
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K233876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: 08/31/2026
• Device Catalogue Number: 8065000468
• Device Lot Number: 172EJL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 06/04/2025
• Date Device Manufactured: 09/26/2024
• 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: UNITY TOTAL PLUS COMBINED PROCEDURE PACK.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown