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

Catalog Number	8065752082
Medical Device Problem Code	Inability to Irrigate (1337)
Health Effect - Clinical Codes	Zonular Dehiscence (2698); Unspecified Eye / Vision Problem (4471); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported though they had several irrigation errors, the cassette passed priming; however, during ultrasound of the nucleus, the irrigation stopped and the anterior chamber in patient¿s right eye collapsed with zonule dehiscence during the cataract procedure.An anterior vitrector was utilized and the procedure was discontinued midway.The patient was scheduled for a reoperation at another facility at a later date.Additional information received from the surgeon who indicated one week later, a re-operation was performed with scleral fixation of an intraocular lens (iol) and it was completed without any problems.
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
A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.It was reported that the anterior chamber collapsed.A wet intrepid plus fluidics management system (fms) was visually inspected and no obvious defects were detected.The sample was tested using an console.The fms primed and tuned with the ultrasonic handpiece, and infusion sleeve from the lab stock successfully.Aspiration and irrigation flow rates met specifications.The root cause of the customer's complaint could not be established; the returned sample functioned per specification.After an investigation of this complaint, no action will be taken at this time as the returned product met specifications.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI 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: 12858492
• Report Number: 1644019-2021-00745
• Device Sequence Number: 4292997
• Product Code: LRO
• UDI-Device Identifier: 00380657520824
• UDI-Public: 00380657520824
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2022

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: 01/31/2023
• Device Catalogue Number: 8065752082
• Device Lot Number: 2458736H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2021
• 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: INFINITI VISION SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female