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

Catalog Number	8065977762
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Endophthalmitis (1835); Vitreous Floaters (1866); Hypopyon (1913); Iritis (1940); Keratitis (1944); Red Eye(s) (2038); Fibrosis (3167)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that during cataract surgery with an intraocular lens (iol) implant procedure, the patient had capsule rupture, so that vitrectomy was performed.Subsequently the patient developed late-onset endophthalmitis.The patient also presented with hyperemia, corneal edema, keratic precipitates, cell, flare, fibrin, anterior chamber empyema, hazy vitreous and difficulty in fundus visualization.After the surgery there was no uncomfortable feeling to the patient.The patient was treated with unspecified corticosteroid eye drops, unspecified antibiotic eye drops, unspecified non-steroidal anti-inflammatory drugs eye drops and a steroid subconjunctival injection.As per the surgeon, capsule rupture, stitches, and nuclear fall occurred were not related to iol.There are two medical device reports associated with this complaint.This report is 2 of 2.Additional information has been requested.
Additional Manufacturer Narrative
Corrected information was provided in d.4.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.
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.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.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The company cartridge was not returned.Product history records were reviewed, and documentation indicated the product met release criteria.A non-qualified lens model was used.The associated company lens is only qualified for use in a company a or company b cartridge.A non-qualified handpiece and a non-qualified viscoelastic were used.The product investigation could not identify a root cause for the reported complaint.Information was provided in the initial report description that during the surgery a capsule rupture occurred.A non-company lens was removed and replaced with the company lens.The file indicated that, per the surgeon, the capsule rupture, two stitches suture, and nuclear fall were not related to the intraocular lens (iol).Additionally, a non-qualified cartridge, handpiece, and viscoelastic were used.File will be reopened if new information or the sample is received.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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C
• Common Device Name: 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: 20513150
• Report Number: 1119421-2024-02051
• Device Sequence Number: 8497540
• Product Code: MSS
• UDI-Device Identifier: 00380659777622
• UDI-Public: 00380659777622
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065977762
• Device Lot Number: 15764661
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 10/24/2024; 12/02/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/19/2024; 12/27/2024
• Date Device Manufactured: 11/28/2023
• 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: 2% XYLOCAINE.; 4% XYLOCAINE.; ACRYSOF MULTIPIECE IOL.; BENOXIL.; BSS STERILE IRRIGATING SOLUTION.; DEXART 1.65MG.; DICLOFENAC.; DISCOVISC.; MYDRIN-P.; NEO-SYNESIN.; OVISOT 0.05G.; ROYAL INJECTOR.; VISCOAT.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 72 YR
• Patient Sex: Male