MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. 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	Flashers (1864); Headache (1880); Visual Disturbances (2140); Anxiety (2328)
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that, after the lens replacement, the patient experienced visual disturbance daily in the form of flashing or strobing.Therefore the patient experienced headache and anxiety.The patient was having these visual disturbances regularly which impacted the quality of life.Hence the walking hours of the patient was miserable.The patient is now looking for the lens replacement although it might be painful and risky.Additional information received stating that, the patient was experiencing the disturbance in the vision everyday, going out was not comfortable.Lighting in stores, restaurants, doctor's offices, homes and more most all cause the flashing.Overhead lighting and lighting coming from lamps at a certain angle generally give the grief.The patient also seem to be having more bright flashes on the outside of the eye when lights hit at certain angle.Since the quality of patient is affected, the patient is proceeding with lens replacement.There are two medical device reports associated with this patient.This report is for right eye.
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 product was not returned for analysis.The root cause for the reported complaint could not be determined.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stating that, the patient had her second lens replacement, after the replacement, the patient's symptoms were resolved.There are two medical device reports associated with this patient.This report is for right eye.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17086115
• Report Number: 9612169-2023-00436
• Device Sequence Number: 2805801
• Product Code: MFK
• UDI-Device Identifier: 00380652408011
• UDI-Public: 00380652408011
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2024

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: 03/01/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.145
• Device Lot Number: 25366522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 07/17/2023; 01/22/2024
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 08/14/2023; 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• 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