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 Disturbances (2140); Halo (2227)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that after intraocular lens (iol) implantation, the patient experienced that the near vision was not good.The patient could not see well and was unable to drive.The iol was replaced with a non-company iol in a secondary procedure.The patient could not tolerate the lens was stated as the clinical reason for explant.According to the additional information received the patient was also bothered by halos and glare.The patient's near vision was not good and the distance vision was okay.In the surgeon's opinion the quality issue with the iol contributed to the events.The patient had a history of dry eye syndrome and puckering of macula in both eyes.The patient's issues were resolved after replacement with a non-company lens.
Additional Manufacturer Narrative
The lens was returned in a plastic bag with a piece of surgical sponge.Solution was dried on the lens.The lens was cut into pieces, typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.Product history records were reviewed and documentation indicated the product met release criteria.The file indicated the use of a qualified cartridge and handpiece, with a non-qualified viscoelastic.The product investigation could not identify a root cause for the reported complaint.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 multifocal company 18.0 diopter, add power +2.2 & 3.2 lens model was replaced with an 18.0 diopter non-company monofocal lens.Due to the exchange of a multifocal lens to a monofocal lens, the replacement lens may have been an improved choice for the patient¿s vision needs.No additional information has been provided at this time.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: 19329921
• Report Number: 1119421-2024-00948
• Device Sequence Number: 16919657
• Product Code: MFK
• UDI-Device Identifier: 00380652413602
• UDI-Public: 00380652413602
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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: 11/16/2025
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.180
• Device Lot Number: 15292143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• 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: AMVISC; L161A0 18.0 SN (B)(6); MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 71 YR
• Patient Sex: Female