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

Model Number	SA60AT
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product 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).
Event or Problem Description
A non-healthcare professional reported during a cataract surgery with intraocular lens (iol) implant procedure, lens was not dispense properly and destroyed.There was no sample available.Additional information has been requested.
Additional Manufacturer Narrative
Additional information has been provided in b.3., b.5., d.10., h.3., h.6., and h.11.The product was not returned.A device history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.The product was not returned.The surgeon indicated the issue may have been related to a lack of viscoelastic in the cartridge.The ifu (instructions for use) instructs to completely fill the cartridge with ovd (ophthalmic viscosurgical device) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received by stating, lens was placed in the cartridge and it would not came out of cartridge as a result lens did not dispensed properly.The procedure was completed on same day.There was no patient harm.

• Brand Name: ACRYSOF 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: 22291655
• Report Number: 1119421-2025-01699
• Device Sequence Number: 8893065
• Product Code: HQL
• UDI-Device Identifier: 00380652555777
• UDI-Public: (01)00380652555777(17)290224(11)240227(10)15809807
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 10/08/2025

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 Model Number: SA60AT
• Device Catalogue Number: SA60AT.185
• Device Lot Number: 15809807
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 10/08/2025
• Date Device Manufactured: 02/27/2024
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown