MAUDE Adverse Event Report: Alcon Research, LLC - Huntington MONARCH III IOL Delivery System, Cartridge D; Folders and Injectors, Intraocular Lens (IOL)

Catalog Number	8065977763
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A non-health care professional reported that during an intraocular lens (iol) implant procedure, it was noticed that the tip of company cartridge was defective.It had loose sharp plastic at the end that caused lens damage.There were no patient contact and no harm to the patient.No further information is expected as reporter unwilling to provide additional information.
Additional Manufacturer Narrative
The used company cartridge was returned with the lens advanced to the nozzle entry area.There is no evidence that the lens was advanced past this position.No viscoelastic was observed past the lens.No loose plastic was observed at the end of the tip.Associated products were not provided.It is unknown if qualified associated products were used.The cartridge tip was bent down and to the left.The bend caused an edge at the end of the tip.This may have been interpreted as the reported complaint.The cartridge had evidence of placement into a handpiece.If the tip is inadvertently pressed against a hard surface the tip could be damaged in this manner.Procedures and processes exist within the manufacturing environment that focus on protection of the cartridge tip.All company cartridges are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company¿s release criteria.Due to the used condition of the device it cannot be verified that the damage was present before use.The lens was not damage.There was no evidence that the lens was advanced to the end of the tip.The lens was at the nozzle entry folded correctly.The customer declined to be contacted for further information.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL Delivery System, Cartridge D
• Common Device Name: Folders and Injectors, Intraocular Lens (IOL)
• Manufacturer (Section D): Alcon Research, LLC - Huntington; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): Alcon Research, LLC - Huntington; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50219295
• Report Number: 1119421-2026-01687
• Device Sequence Number: 13406218
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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 Catalogue Number: 8065977763
• Device Lot Number: 16193977
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2026
• 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: Unspecified lens
• Patient Sex: Unknown