MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.Root cause has not been identified.Six photos were provided, three were duplicates.The first photo showed the lens case base on a surface.The yellow single-piece lens was on the outer rim of the case.A triangular portion had been cut from the optic.The portion was inside the lens case well area.The haptic on this portion was broken.A company-provided cartridge was visible above the lens case.There appeared to be viscoelastic in the cartridge.The broken haptic was visible pressed up against the roof of the cartridge, just before the nozzle entry area.The cartridge loading area was not visible.The second photo showed the monarch from the loading area to the tip.Viscoelastic was visible in the cartridge.The broken haptic was visible pressed up against the roof of the cartridge, just before the nozzle entry area.The cartridge had evidence of placement into a handpiece.The third photo showed the lens case lid with complaint product serial number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that during intraocular lens (iol) implantation, when the lens was placed and before rotating it with the rotator, the haptic became loose.The lens was subsequently removed in an initial procedure.Additional information has been requested but is not available at the time of this report.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• 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 ; 8007579780
• MDR Report Key: 25271190
• Report Number: 1119421-2026-01119
• Device Sequence Number: 9703462
• Product Code: HQL
• UDI-Device Identifier: 00380655093221
• UDI-Public: (01)00380655093221(17)301008(11)251010(10)16131449
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2026

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: SN60WF
• Device Catalogue Number: SN60WF.215
• Device Lot Number: 16131449
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/25/2026
• Date Device Manufactured: 10/10/2025
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Patient Sex: Male