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

Model Number	CC60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, there was an unexpected outcome after cataract surgery in the left eye.The consumer could not see to drive but could see to read up close.The consumer was seen by an optometrist and was told nearsighted.The consumer saw the eye chart well through the lenses during refraction.The consumer had expected to see at distance.The consumer was scheduled to see the surgeon the following week.Additional information has been requested.
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
Additional information has been requested and received stating that the patient followed up with the surgeon who described the outcome as a myopic surprise.The patient felt that something definitely went wrong either in the measurements, or the wrong lens was inserted.The patient could still only see up close and not at a distance.The patient planned to get a second opinion in (b)(6) 2025.In the meantime, the patient decided not to proceed with cataract surgery on the right eye until seeing a different surgeon.The doctor providing the second opinion did not want to see the patient until (b)(6) 2025 as they wanted the left eye to heal before taking any further action.
Additional Manufacturer Narrative
Additional information was provided in b.5.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC UV ABSORBING 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: 23016601
• Report Number: 1119421-2025-02445
• Device Sequence Number: 9573028
• Product Code: HQL
• UDI-Device Identifier: 00380652396783
• UDI-Public: (01)00380652396783(17)281015(11)241017(10)15938322
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: CC60WF
• Device Lot Number: 15938322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/16/2025
• Date Device Manufactured: 10/17/2024
• 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: Other
• Patient Sex: Female