MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWTT4
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	03/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that after intraocular lens (iol) implantation, the patient had halos, starburst and cloudy periphery.The lens was explanted and replaced with non-company lens in a secondary procedure.Additional information received stated that patient's right eye was involved and the patient's issues had been resolved.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.The lens was cleaned for further evaluation.Light scratches are observed on both the anterior and posterior sides of the optic.A small nick is observed to the outer edge of a haptic in the distal area.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicates the use of a qualified cartridge.The file also indicates the use of a company handpiece and a non-qualified viscoelastic.The product investigation could not identify a root cause for the reported complaint.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.The company (2.25), 16.5 diopter (add power +2.2/+3.2) lens was replaced with a monofocal lens.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: 17002680
• Report Number: 1119421-2023-00964
• Device Sequence Number: 7151143
• Product Code: MJP
• UDI-Device Identifier: 00380652457842
• UDI-Public: 00380652457842
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/25/2023

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: 03/29/2025
• Device Model Number: CCWTT4
• Device Catalogue Number: CCWTT4.165
• Device Lot Number: 15301514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 05/25/2023
• Date Device Manufactured: 11/05/2021
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; OCCUCOAT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown