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)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.One haptic was broken in the distal area (not returned).The lens is cut in half, typical of insertion and removal from the eye.A power and resolution inspection could not be conducted due to extensive damage.Product history records were reviewed and the documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause.The power and resolution of each lens was 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Information was provided that the multi-focal toric company lens was replaced with a non-company monofocal lens.Due to the exchange of a multifocal toric lens to a monofocal lens, this may suggest that the replacement lens model was an improved choice for the patient's vision needs.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 not happy with the vision, clinical reason being presbyopia.The iol was explanted and exchanged for a non company lens following the initial implant procedure.Additional information has been requested.

• 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: 17433825
• Report Number: 1119421-2023-01358
• Device Sequence Number: 6834691
• Product Code: MJP
• UDI-Device Identifier: 00380652457446
• UDI-Public: 00380652457446
• 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: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/01/2023

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: 07/04/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.230
• Device Lot Number: 15440912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2022
• 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: MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female