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	Dry Eye(s) (1814); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported, following an intraocular lens (iol) implant procedure.The patient experienced daytime glare, bad night glare, starbursts, dry eye and halos.The patient undergone, for laser procedure.Post procedure: the patient can see clearly, but nothing for the glare issues.There are two medical device reports associated with this patient.This report is associated with the right eye.Additional information was requested.
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 lens remained implanted.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.The lens remained implanted.Each lens is subjected to a 100 percentage assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The patient indicated they had prior glare before the surgery.The patient was the reporter.The consumer was informed that company is unable to provide medical advice or recommendations.The patient was advised to speak to surgeon regarding issues they are experiencing or seek a second opinion.The patient indicated that they have dry eyes and were instructed to use gel at night and wear reading glasses however, none of this has helped with the glare issues.A second opinion will be sought and the appointment is in (b)(6) 2024.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated that the patient experienced positive dysphotopsia, poor quality of vision and mild hyperopia.The lens was replaced with the company lens.No patient harm.
Additional Manufacturer Narrative
The lens was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.The lens has not returned.Each lens is subjected to a 100 percentage assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The patient indicated they had prior glare before the surgery.The patient was the reporter.The consumer was informed that company is unable to provide medical advice or recommendations.The patient was advised to speak to surgeon regarding issues they are experiencing or seek a second opinion.The patient indicated that they have dry eyes and were instructed to use gel at night and wear reading glasses; however, none of this has helped with the glare issues.A second opinion was sought.The lens was explanted.The multifocal company model 23.5 diopter (add power plus2.2 or plus 3.2 diopter) was removed and replaced with a monofocal toric company model (1.50 cylinder) 24.0 diopter lens.Information was provided that the replacement lens model and diopter was chosen aiming for distance axis 30.Mild hyperopia noted with prior lens increase power by one step.Due to the exchange of multifocal lens to a monofocal toric lens, and the information provided, this suggests that the replacement lens may have been an improved choice for the patients vision needs.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).

• 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: 19711178
• Report Number: 1119421-2024-01295
• Device Sequence Number: 8608482
• Product Code: MFK
• UDI-Device Identifier: 00380652413718
• UDI-Public: (01)00380652413718(17)270410(11)230412(10)15618278(21)15618278009
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/12/2024

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 Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.235
• Device Lot Number: 15618278
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 08/29/2024; 11/13/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 09/26/2024; 12/12/2024
• Date Device Manufactured: 04/12/2023
• 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: AMVISC PLUS OVD.; MONARCH II IOL , INJECTOR.; MONARCH III IOL , CARTRIDGE D.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Female