MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWTT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Vitreous Floaters (1866); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
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).
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 on eye to clean up debris the surgeon saw in the eye which caused me now to have very annoying floaters.There are two medical device reports associated with this patient.This report is associated with the left eye.Additional information was requested.
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).
Additional Manufacturer Narrative
Correction information was provided in d.4.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in b.3., b.5., b.6., d.6.B., h.6.And h.11.The lens has 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 100percentage 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 toric company (1.50 cylinder) 23.5 diopter (add power plus 2.2 or plus 3.2 diopter) lens was removed and replaced with a monofocal noncompany 22.5 diopter lens.Due to the exchange of multifocal toric lens for a monofocal lens, this suggests that a monofocal 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).
Event or Problem Description
Additional information has been received and stated that the patient experienced positive dysphotopsia and poor quality of vision.The lens was replaced with another lens.The patient underwent for yag laser capsulotomy prior to explant.

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 19718746
• Report Number: 1119421-2024-01298
• Device Sequence Number: 8130385
• Product Code: MJP
• UDI-Device Identifier: 00380652457453
• UDI-Public: (01)00380652457453(17)250325(11)211101(10)15294480(21)15294480063
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/11/2024

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: 03/25/2025
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.235
• Device Lot Number: 15294480
• 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; 09/29/2024; 11/13/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 09/28/2024; 10/28/2024; 12/11/2024
• 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; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female