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

Model Number	CCW0T3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Diplopia/Double Vision (4802)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device 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 facility representative reported that following an intraocular lens (iol) implantation procedure, the patient was unable to see clearly and experienced occasional diplopia.The lens was explanted and replaced with a different lens during a secondary procedure.The clinical reason for the explant was identified as a refractive surprise.Additional information was requested.
Additional Manufacturer Narrative
Additional information provided in d.9., d.10., h.3., h.6.And h.11.The lens was returned inside a plastic specimen jar.Viscoelastic was dried on the lens.The optic was cut into three portions (returned), typical of an insertion and removal.The lens was cleaned with klrp for further evaluation.No additional damage was observed to the cut portions of optic.A recheck of the power (sphere and cylinder) and resolution of the lens could not be conducted due to the lens was cut into multiple portions.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.A qualified cartridge and handpiece were used.Viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The product investigation could not determine the root cause for the reported visual complaint.The lens was returned cut into multiple pieces, typical in appearance to an insertion and removal.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 power and resolution of the returned lens could not be re-evaluated due to the optic damage.Clinical reason for the explant is refractive surprise.The toric monofocal 19.0 diopter lens was removed and replaced with an unspecified monofocal.It is unknown if the replacement monofocal was a toric monofocal.The replacement lens diopter was also not provided.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 23005555
• Report Number: 1119421-2025-02429
• Device Sequence Number: 18603926
• Product Code: MJP
• UDI-Device Identifier: 00380652431811
• UDI-Public: (01)00380652431811(17)271218(11)231220(10)15768728
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2025

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: CCW0T3
• Device Lot Number: 15768728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/08/2025
• Date Device Manufactured: 12/20/2023
• 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: CLAREON MONARCH IV IOL, INJECTOR; MCPHERSON FORCEPS; MONARCH III IOL CARTRIDGE D; PROVISC OVD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown