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	Conjunctivitis (1784); Vitreous Floaters (1866); Blurred Vision (2137); Visual Impairment (2138); Discomfort (2330)
Date of Event	02/06/2023
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 facility representative reported that following an intraocular lens (iol) implant procedure, the patient was dissatisfied with the lens.He could not see the golf ball, has floaters, feels pressure around eye.He has seen an optometrist and was told his eye look fine.He has an appointment to see surgeon in november.Additional information has been requested.There are two medical device reports associated with this patient.This report is associated with the right eye.
Event or Problem Description
Additional information has been requested, received and stated the patient have intense displeasure with the lens, pink sclera, blurred vision, and inability to drive at night due to intensity of car headlights.He is going to request surgeon for the company lens to be removed and replace with the basic accommodative toric lens in the upcoming appointment.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
B3 (event date), b2 (event outcome) and e1 (initial reporter first name).The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated the patient had decreased vision at distance, severe glare at night.The iol was exchanged for an unspecified monofocal toric lens.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
The lens was returned adhered to gauze inside a specimen cup.Viscoelastic was dried on the lens.The lens was cleaned with klrp to remove from the gauze and facilitate further testing.The optic had two small, cracked areas, which appear to have been caused by an instrument used to grasp the lens.The optic also had a scratch on the anterior surface near the edge.The root cause for the reported issues cannot be determined.Power and resolution were verified.The lens met specification for power and resolution for a company (1.50cyl), 20.0 diopter lens.In addition, each lens is subjected to a 100% 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.The initial reporter (patient) stated they had seen an optometrist who found no issues.A facility representative reported the patient had decreased vision at distance and glare at night was severe.The replacement lens was indicated to be a monofocal toric.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: 17668980
• Report Number: 1119421-2023-01542
• Device Sequence Number: 7068106
• Product Code: MJP
• UDI-Device Identifier: 00380652457385
• UDI-Public: 00380652457385
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/16/2024

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 Expiration Date: 02/18/2025
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.200
• Device Lot Number: 15252007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 10/02/2023; 01/22/2024; 03/19/2024
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/27/2023; 02/16/2024; 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2021
• 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 II LOADING FORCEPS; MONARCH III IOL CARTRIDGE D; PROVISC
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male