MAUDE Adverse Event Report: ALCON GRIESHABER AG MONARCH II LOADING FORCEPS; FORCEPS, OPHTHALMIC

Catalog Number	560.01
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A physician reported that during cataract surgery, an ophthalmic forceps had foreign material adhered which was used with the cartridge could not be completely removed.The surgery was completed on the same day.No patient impact was reported.
Additional Manufacturer Narrative
A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A review of the database for the non-conformance events and the complaints showed that the given lot number was not concerned by any relevant deviation and that there are no additional complaints associated with the given production lot.The instrument is not expected by the investigation site for evaluation and the investigation is completed without identifying a root cause.The instrument was not received at the investigation site and not enough information was provided for further investigation.Therefore, the root cause for the customer complaint issue cannot be determined conclusively.The exact root cause for the customer's reported event is unknown, therefore, specific action cannot be taken.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH II LOADING FORCEPS
• Common Device Name: FORCEPS, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer (Section G): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21100414
• Report Number: 3003398873-2025-00007
• Device Sequence Number: 8818453
• Product Code: HNR
• UDI-Device Identifier: 07612717057470
• UDI-Public: (01)07612717057470(17)310831(11)210901(10)14297T
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 04/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 560.01
• Device Lot Number: 14297T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 04/25/2025
• Date Device Manufactured: 09/01/2021
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL; HEALON; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Patient Sex: Unknown