MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A non-health care professional reported that during an intraocular lens (iol) implant procedure, possible defect on the lens.Additional information was requested.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The lens was returned positioned correctly in the #78(iw) lens case inside the lens carton.Solution was dried on the lens.The lens was cleaned with klrp (klotho-related protein) to further evaluate.There was no damage or defect observed.A dimensional inspection (plan view) was conducted.The lens was within the specification per the approved template.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 complaint was reported as "possible defect on lens".The specific "defect" or damage was not provided.The returned lens was evaluated.The product met specification.There was no damage or defect observed.A dimensional inspection (plan view) was conducted.The lens was within the specification per the approved template.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC 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: 23943573
• Report Number: 1119421-2026-00019
• Device Sequence Number: 10683627
• Product Code: HQL
• UDI-Device Identifier: 00380652251396
• UDI-Public: (01)00380652251396(17)290630(11)250702(10)16068832
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: SY60WF
• Device Catalogue Number: SY60WF.155
• Device Lot Number: 16068832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• 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