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

Model Number	SY60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
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 nurse reported following an intraocular lens (iol) implant procedure, the patient experienced unexpected optical surprise.The lens was explanted and replaced with unspecified lens in a secondary procedure.The clinical reason for the explant was mentioned as optical surprise.Additional information was requested.
Additional Manufacturer Narrative
Correction information was provided in b.2., b.5.And h.11.Based on the available information following submission of the initial report, this event does not meet the criteria for classification as a serious injury.No further reports are required.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and reported that the iol was exchanged for the different lens model but same diopter power indicating the correct lens power was not implanted initially.There is no reported defect or fault with the iol.

• 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: 23004303
• Report Number: 1119421-2025-02424
• Device Sequence Number: 9413142
• Product Code: HQL
• UDI-Device Identifier: 00380652251518
• UDI-Public: (01)00380652251518(17)280730(11)240801(10)15899164
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SY60WF
• Device Catalogue Number: SY60WF.215
• Device Lot Number: 15899164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/28/2025
• Date Device Manufactured: 08/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown