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	Vitreous Floaters (1866); Blurred Vision (2137); Visual Impairment (2138); Diplopia/Double Vision (4802)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 consumer reported that following intraocular lens (iol) implantation, the patient experienced difficulty with depth perception.The patient stated that the ground appeared uneven and that judging level surfaces (e.G., while raking the garden) was difficult.The patient also reported that their vision seemed to be worsening.Additional information has been requested but is not available at the time of this report.
Event or Problem Description
Additional information has been received and stated that the patient experienced blurry vision and cloudy vision.As per surgeon opinion the shadow from old stroke/trauma & visual field defect or shadow from the prominent posterior vitreous detachment (pvd).
Additional Manufacturer Narrative
The product was not returned.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 lens remains implanted.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The surgeon has indicated the issue is not related to the lens.The provided neuro-ophthalmology report from 31-jul-2024 indicated the patient has a weiss ring that was causing intermittent metamorphopsia and clouding of vision.It was indicated that the patient was counseled that the visual symptoms are due to the weiss ring and partial pvd.On 04-feb-2026 the surgeon provided information that the issues were due to old stroke/trauma and visual field defect/shadow from prominent pvd noted in the pre-op exam on (b)(6) 2024.The patient was last seen (b)(6) 2025.The reporter was the patient.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: 24469981
• Report Number: 1119421-2026-00406
• Device Sequence Number: 9581738
• Product Code: HQL
• UDI-Device Identifier: 00380652396820
• UDI-Public: (01)00380652396820(17)261106(11)221108(10)15529918
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 15529918
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 02/28/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/17/2026
• Date Device Manufactured: 11/08/2022
• 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 II LOADING FORCEPS; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR; PROVISC OVD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Male