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	Visual Impairment (2138); Halo (2227)
Date of Event	10/27/2022
Type of Reportable Event	Serious Injury
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced halos around every light and at night felt like living in a nightmare.The patient was unable to drive at night.The doctor told patient that if the eyes had not improved by the time, they probably never would.Patient was unhappy with the outcome.Additional information has been requested and received that patient was prescribed eye drops, and then used over the counter eye drops for dryness.The doctor gave some drops to use before going out at night.But was not used.The patient said that usually uses tinted glasses at night and exploring clear lenses with a non-glare coating, but didn't find any difference.He also stated that the lenses were great during the day.And he doesn't need glasses for reading, sewing or any other close work.There are two medical device reports associated with this file.This report is associated with the (os) file.

• 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: 17728887
• Report Number: 1119421-2023-01593
• Device Sequence Number: 6164443
• Product Code: MFK
• UDI-Device Identifier: 00380652413619
• UDI-Public: 00380652413619
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 09/12/2023

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: 03/25/2025
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.185
• Device Lot Number: 15288082
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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: Other
• Patient Sex: Female