MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; FOLDERS AND INJECTORS , INRAOCULAR LENS (IOL)

Model Number	IV
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported a risk of lens damage as the plunger slipped under the lens into the cartridge.The surgery was completed with back up lens.Additional information has been requested.
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
Additional information provided in a2., a3.A., a.4.B.5., and d.9.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that type of procedure planned was refractive lens exchange (rle).There was no patient contact between the patient and iol.
Additional Manufacturer Narrative
Additional information provided in h.3.H.6 and h.11.A sample was not received at the manufacturing site for evaluation for the report that the plunger slipped under the lens; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The investigation conducted a non-conformance review of the reported lot number.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Based on the evaluation of the information received, the investigation was unable to identify the root cause or origin of the reported event.Additionally, no manufacturing-related deficiencies were found that potentially could have contributed to the complaint.While the root cause and its origin are inconclusive, the following factors outlined in the reported product¿s instruction for use (ifu) could potentially contribute to an outcome similar to the reported event.The ifu states that the handpiece must be inspected prior to each use to confirm it is free of damage.It further emphasizes that if the handpiece¿particularly the plunger tip, appears damaged, bent, or otherwise unfit for proper use, it must not be used.In such cases, users are instructed to contact alcon immediately.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR
• Common Device Name: FOLDERS AND INJECTORS , INRAOCULAR LENS (IOL)
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23977777
• Report Number: 2523835-2026-00022
• Device Sequence Number: 14591066
• Product Code: MSS
• UDI-Device Identifier: 00380659777745
• UDI-Public: (01)00380659777745(17)320630(11)220616(10)14ULVM
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K212039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2026

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 Model Number: IV
• Device Catalogue Number: 8065977774
• Device Lot Number: 14ULVM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 01/08/2026; 03/13/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/02/2026; 04/07/2026
• Date Device Manufactured: 06/16/2022
• 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 VIVITY EXTENDED VISION HYDROPHOBIC IOL.; HEALON PRO.; UNSPECIFIED CARTRIDGE.
• Patient Sex: Unknown