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

Model Number	CCWTT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	08/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported a poor visual outcome after cataract surgery about a patient 3 weeks post operative.She cannot read print, text, or smaller street signs.Her intermittent vision was ok.She used to be able to see the edge of leaves and sharp in the distance without effort.Now everything was a struggle.She was afraid to have the left eye done because she would not be able to function.Surgeon had said that likely prior ortho-k treatment 20 years ago may have to do with the outcome.She recalled her eye was dry and irritated on pre-op measurements.She thinks the doctor picked the wrong lens.Her vision was 20/20 distance without correction, her intermediate was 20/40 and her near was 20/63 without correction.Her refraction was plano.Surgeons prognosis was about 1/3 will adapt and the others can exchange the iol with good outcome.She was waiting another month.Additional information was received stating that her symptoms continue and she still thinks the surgeon has implanted wrong lens.She has decided to have 2nd opinion.
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
Also, information received stating that 20/unhappy at 7 weeks post op.She was offered two options 1) wait a little longer to adapt or 2) exchanged the lens.She wanted to think about it.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 17938871
• Report Number: 1119421-2023-01763
• Device Sequence Number: 2982921
• Product Code: MFK
• UDI-Device Identifier: 00380652413596
• UDI-Public: 00380652413596
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 11/16/2023

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 Expiration Date: 05/09/2026
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.175
• Device Lot Number: 15404772
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 10/21/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• 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: AMVISC; MONARCH III IOL, CARTRIDGE D
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female