MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CNWTT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that following a cataract extraction with intraocular lens (iol) implant procedure, the patient experienced multiple severe side effects i.E., night blindness, severe glare, foggy blurry vision, feel of a veil over eyes, depth perception problems, quiver feel in eyes, decrease in vision clarity.Additional information received consumer also stated that driving was treacherous from dusk to dark, car headlights look like huge blobs of lights with rings and starbursts without being able to determine if the light was single light or 2 headlights and cannot even determine if the vehicle is a motorcycle, car, pickup truck or semi-truck or if the vehicle is partially in the lane.The daytime driving was also affected, and cars are blurry as well as road signs.Patient can¿t read the signs until almost next to them, and cannot read a license plate in front, unless consumer stopped in traffic or at a light.The consumer became anxious while driving.Even in the kitchen table the patient not able to see stove or microwave which is 15 feet away.No further information available.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stated that patient had a yag (yttrium aluminum garnet), but did not improve a vision, and feels that vision was getting worse, and the patient cannot go out at night.The patient was put on multiple drops with no relief.Patient ended up with lifetime concentric circles, blurriness, starbursts, halos and glare around all lights more pronounced at dusk, dawn and darkness.In addition, intermediate (15-20ft.) and distance has been decreasing gradually and lately, had even noticed near vision was not as clear and ifestyle has been drastically affected.
Additional Manufacturer Narrative
Additional information provided in b.2., b.5.And h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received stated that patient vision was effected by the lenses that was implanted.
Additional Manufacturer Narrative
Associated products were not provided.It is unknown if qualified products were used.The patient was encouraged to speak to their eyecare provider regarding the problems they are having.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in b.5.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received stated that she continues to have issues with the lens.Experiencing glare issue at night driving and the sunlight is very bright.Her near vision has improved greatly and distance vision has improved little.No further information available.

• Brand Name: CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC 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: 15233481
• Report Number: 1119421-2022-01773
• Device Sequence Number: 4768704
• Product Code: MFK
• UDI-Device Identifier: 00380652408097
• UDI-Public: 00380652408097
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/13/2023

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: 01/16/2025
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.185
• Device Lot Number: 15258246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 08/25/2022; 10/05/2022; 01/26/2023
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 09/19/2022; 11/02/2022; 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 75 YR
• Patient Sex: Female