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); Hyperemia (1904); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Excessive Tear Production (2235); Discomfort (2330)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
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, constantly weeping, bloodshot and blurred.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 left eye.
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).
Additional Manufacturer Narrative
Additional information provided in b.5.And h.6.The manufacturer internal reference number is: (b)(4).
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 product was not returned.Qualified associated products were indicated.The product investigation could not identify a root cause.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.Information was provided that the current company model (1.50), 20.0 diopter (add power +2.2/+3.2) lens was replaced with a different model company (3.25cyl), 20.5 diopter lens.Due to the exchange of a multifocal toric lens to a monofocal toric lens, this may suggest that the replacement lens model was an improved choice for the patient's vision needs.The file will be reopened if additional information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated the patient had severe glare and halos at night.The iol was exchanged for another model company lens.There was no patient harm.

• 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: 17668981
• Report Number: 1119421-2023-01543
• Device Sequence Number: 7068107
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2024

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: 11/29/2025
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.200
• Device Lot Number: 15309586
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 10/02/2023; 03/15/2024
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/27/2023; 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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: ALCON FORCEPS; CLAREON MONARCH IV IOL INJECTOR; MONARCH CARTRIDGE D; PROVISC
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male