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

Model Number	CCWTT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurry vision.Clinical reason for explant was presbyopia.The iol was exchanged for non-company monofocal lens model 04 months 11 days following the initial implant procedure.As per surgeon opinion product did not cause or contributed to event.Additional information has been requested.
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).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6., and h.11.The lens was returned in a specimen cup.Solution was dried on the lens.The optic had deep split/cracks in the central optic zone.Power and resolution testing could not be conducted due to the extensive optic damage.Product history records were reviewed, and documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.Power and resolution testing could not be conducted due to the extensive optic damage.Each lens is subjected to a 100 percentage assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that in the surgeon's opinion, the product did not cause or contribute to the event.The file indicated that the multifocal toric company 15.5 diopter (1.50cyl), add power +2.2 and 3.2 lens model was exchanged for a non-company, non-toric, monofocal, 15.0 diopter lens model.Due to the exchange of a multifocal toric lens to a monofocal non-toric lens, the replacement lens may have been an improved choice for the patient's vision needs.No additional information has been provided at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20268539
• Report Number: 1119421-2024-01878
• Device Sequence Number: 17952156
• Product Code: MJP
• UDI-Device Identifier: 00380652457293
• UDI-Public: (01)00380652457293(17)270318(11)230320(10)15599748
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: CCWTT3
• Device Catalogue Number: CCWTT3.155
• Device Lot Number: 15599748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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 DELIVERY SYSTEM, INJECTOR.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male