MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Catalog Number 8065977763

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Uveitis (2122); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/16/2022

Event Type  Injury  

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 Description

A physician reported that after a cataract surgery patient experienced inflammation (fibrin) and endophthalmitis.Patient was given with an antibacterial agent and the condition was improving.It was informed that the patient was in contact with ophthalmic cartridge, surgical procedure packs, viscoelastics, ophthalmic phacoemulsification tip, ophthalmic phacoemulsification handpiece and irrigation/aspiration tip.Additional information was received clarifying the surgeon confirmed the event was tass (toxic anterior segment syndrome).

Manufacturer Narrative

The product was not returned.Product history records were reviewed, and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Information was provided that the surgeon considers that the event was toxic anterior segment syndrome , and possibility causalities of the event were cleaning the handpiece and reuse of cassette pak.The surgeon judged that there was no malfunction with the product.As there was no problem with the product, there was no causality between the event and the product.There are two complaints in the lot from this facility.Investigation has been completed based on current information.Based on our current tracking, there are no adverse trends for this reported complaint.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13867070
• MDR Text Key: 288111052
• Report Number: 1119421-2022-00554
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: 15276668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACCESSORY, OZIL TORSIONAL HANDPIECE; CENTURION SURGICAL PROCEDURE PAK; CONSTELLATION SURGICAL PROCEDURE PAK; CONSTELLATION VISION SYSTEM; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; INFINITI VISION SYSTEM, HANDPIECE TIP; IOL, UNSPECIFIED; IRRIGATION AND ASPIRATION TIPS
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female