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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Corneal Edema (1791); Eye Injury (1845); Visual Impairment (2138); Corneal Endothelial Cell Loss (4806)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device 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.
Event or Problem Description
An account manager reported with a description of crack on lens after implantation.Lens was explanted in a initial procedure.Additional information has been received as surgeon attempted to implant a company +29.5 iol using a company cartridge, but the lens was found to be fractured near the optic.After consulting another physician, the lens was removed and replaced with another company +29.5 using a cartridge (uncertain if it was the same one).However, the second lens also showed a fracture near the optic center.Due to iris trauma from the first lens removal and no additional +29.5 iols available, the decision was made to leave the fractured lens in situ and close the case.One week post-op, the patient reported 20/80 vision, with corneal edema likely contributing, possibly due to endothelial damage, iris trauma, or the fractured optic.

• 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: 21440702
• Report Number: 1119421-2025-00480
• Device Sequence Number: 19984495
• Product Code: MSS
• UDI-Device Identifier: 00380659777622
• UDI-Public: (01)00380659777622(17)270724(11)240725(10)15893740
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K112977
• 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
• Report Date (Section B): 02/22/2025

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 Catalogue Number: 8065977762
• Device Lot Number: 15893740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 02/22/2025
• Date Device Manufactured: 07/25/2024
• 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: CLAREON ASPHERIC UV ABS.G IOL.; CLAREON ASPHERIC UV ABS.G IOL.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown