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

Model Number	SN60WF
Medical Device Problem Codes	Material Discolored (1170); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that during intraocular lens (iol) implant procedure, the surgeon noticed that lens color was slightly different from routine lens and the behavior while loading was also very different and felt rigid than routine.There was no patient contact.Additional information was requested.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6., and h.11.The product was not returned.Three photos were provided of the lens carton from the top, bottom and the label endcap.The lens case was also visible in the caron window of the first photo.The lens was not pictured 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.The product investigation could not identify a root cause for the reported complaint.The product was not returned.No determination can be made without physical evaluation of the sample.Three photos were provided of the lens carton.The lens was not pictured.All lenses are 100% inspected for cosmetic attributes and abnormal color would not have met release criteria.The manufacturer internal reference number is:(b)(4).

• 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: 23381500
• Report Number: 1119421-2025-02787
• Device Sequence Number: 4939956
• Product Code: HQL
• UDI-Device Identifier: 00380655093238
• UDI-Public: (01)00380655093238(17)300329(11)250331(10)16014524
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• 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): 12/16/2025

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: SN60WF
• Device Catalogue Number: SN60WF.220
• Device Lot Number: 16014524
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/16/2025
• Date Device Manufactured: 03/31/2025
• 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
• Patient Sex: Unknown