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	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	10/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that, after intraocular lens implantation surgery, the patient was not happy with vision.Hence the lens was explanted and replaced with another lens in a secondary procedure.The clinical reason for explant was other mechanical complications of lens.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution and blood are dried on the lens.The lens is cut in half, typical of insertion and removal from the eye.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 file indicates that the multifocal, 18.0 diopter (add power +2.2/+3.2) lens was replaced with an 18.5 diopter monofocal lens.Due to the exchange of a multifocal 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
Additional information was received stating that, the patient had some glare.The surgeon stated that, the patient was given 1.0 d scl trial and the patient confirmed that the vision was clear but there was still some haze.
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: 18516624
• Report Number: 1119421-2024-00107
• Device Sequence Number: 6732303
• Product Code: MFK
• UDI-Device Identifier: 00380652413602
• UDI-Public: 00380652413602
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2024

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: 12/15/2025
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.180
• Device Lot Number: 15325447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 01/10/2024; 02/07/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/05/2024; 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2021
• 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 INJECTOR.; DUOVISC.; GREISHABER FORCEPS.; MONARCH III CARTRIDGE D.; RXLAL 18.5 SN (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female