MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNWTT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that after intraocular lens (iol) implant procedure, the patient experienced trouble reading road signs, had glare, halos, and a spider-web appearance in her vision several days following the implantation of each eye.Additionally claims that she can see the edge of her lens when she looks left (not sure which eye) and the vision is 20/20, and the implanting surgeon and their other associates have not found anything clinical.There are two medical reports associated with this patient.This file belongs to right eye.Additional information was requested, but no further information is available.
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
Corrected information provided in d4.Additional information has been provided in h.3., h.6., and h.11.The product was not returned for analysis.The root cause for the reported complaint could not be determined.The instructions for use (ifu) states that some visual effects may be expected due to the superposition of focused and unfocused multiple images, these may include some perception of halos, radial lines around point sources of light (starbursts) under night-time conditions, or glare, as well as other visual symptoms.As with other multifocal intraocular lens (iol), there is a possibility that visual symptoms may be significant enough that the patient will request explant of the multifocal iol.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 19850267
• Report Number: 9612169-2024-00749
• Device Sequence Number: 6409582
• Product Code: MJP
• UDI-Device Identifier: 00380652468510
• UDI-Public: (01)00380652468510(17)250112(11)210821(10)25255814
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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: 01/12/2025
• Device Model Number: CNWTT3
• Device Catalogue Number: CNWTT3.190
• Device Lot Number: 25255814
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 10/25/2024
• Date Device Manufactured: 08/21/2021
• 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 Age: 71 YR
• Patient Sex: Female