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 Codes	Retinal Detachment (2047); Blurred Vision (2137); Loss of Vision (2139); Visual Disturbances (2140)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause.The lens remained implanted.The power (sphere and cylinder) and resolution of each lens is 100 percent evaluated during the manufacturing process to determine acceptability per model and diopter.Per the patient, the surgeon did not implant the lens in the capsular bag but in front of the bag.Per the ifu: the uv absorbing intraocular lens (iol) is indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia and the reduction of residual refractive astigmatism, in adult patients in whom a cataractous lens has been removed.The lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal iol.The patient was the reporter.Per the patient, it had been conveyed to them that the cataract surgery could increase the risk for rd (retinal detachment).Information had been provided to the patient to seek the opinion of a medical professional.While company manufactures the lenses, we are not doctors and are not at liberty to give opinion, advice, or suggestions.The consumer was urged to update company with any further details for this event.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A consumer reported that after implantation of intraocular lens, his vision was blurry at all distances, has streaks of light at night/ sees starbursts at night.Additional information was received from consumer stating from last few days his vision has gone blurry in the upper right quadrant, like the face of a clock.The symptoms are ongoing at the time of follow up report.Further additional information was reported by the consumer stating he had laser and a gas bubble on his od for a retinal detachment (rd).He also found out his cataract surgeon did not put the lens in the capsular bag but in front of the bag.He was told cataract surgery could increase the risk for rd.

• 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: 20793159
• Report Number: 1119421-2024-02308
• Device Sequence Number: 7894853
• Product Code: MJP
• UDI-Device Identifier: 00380652457385
• UDI-Public: (01)00380652457385(17)270425(11)230427(10)15639006
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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: CCWTT3.200
• Device Lot Number: 15639006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/27/2024
• Date Device Manufactured: 04/27/2023
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male