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); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Posterior Capsule Opacification (4807)
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 couldn't see clearly and wanted bright lighting , diffractive nature and different focal lengths with lens.The patient felt this should be fixed in the lenses.The surgeon told to wait till the vision resolves over time and was told not to have lens exchange.The patient had laser procedure at time of iol implant to treat the corneal astigmatism.Additional information has been requested.There are two medical device reports associated with this file.This report is associated with the left eye.
Event or Problem Description
Additional information has been received the upon examination of eye patient also diagnosed with meibomian gland deficiency.
Additional Manufacturer Narrative
The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.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.The reporter was the patient.Global quality customer affairs (gqca) has corresponded with the patient regarding their issues and available resources.Further information was provided by medical product information.The reporter indicated that their vision improved with increased lighting.During the last conversation with gqca the reporter indicated that a corneal specialist had diagnosed meibomian gland deficiency (blepharitis) which may affect visual acuity.The reporter did not want company to reach out to their surgeon at this time.No further information has been provided.The file will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
A facility representative reported the lens was explanted with reason of poor contrast, blur, intolerance to multifocal and pco.The company lens was replaced with an unspecified monofocal lens.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 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: 18160856
• Report Number: 1119421-2023-01925
• Device Sequence Number: 20468546
• Product Code: MFK
• UDI-Device Identifier: 00380652408073
• UDI-Public: 00380652408073
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2024

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: 03/07/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.175
• Device Lot Number: 15364006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 01/05/2024; Not provided
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 01/30/2024; 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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 Age: 76 YR
• Patient Sex: Male