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	Visual Disturbances (2140); Halo (2227)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient as glare/halos and clinical reason for explant being measurement issue.The iol was explanted and exchanged for a non company atiol following the initial implant procedure.Additional information has been requested and received stating that the symptoms were resolved.
Additional Manufacturer Narrative
The lens was returned on a piece of white medical sponge in a ziploc baggie.Solution was dried on the lens.The optic was cut into two pieces, typical of an insertion and removal.One optic portion has a small cracked area near the edge.The other optic portion has a scratched area with small crack damage near the optic edge.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge, handpiece, and viscoelastic.The root cause cannot be determined for the reported complaint of "explant; can't tolerate glare/halos; measurement issue".The lens was returned cut into two portions, typical of an insertion and removal.Additional optic damage was observed.Each lens is subjected to a 100% assessment of the power (sphere and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.The company lens (1.50 cyl.) 17.0 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a non-company, monofocal toric 17.0 diopter lens.This information of replacing the multifocal toric lens with a monofocal toric lens may suggest that the replacement lens was an improved selection for this patient's vision needs or preferences.Follow up attempts were made for more clarification.No further clarification has been provided.If additional information becomes available, the file will be reopened and updated.The manufacturer internal reference number is: (b)(4).

• 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: 18930520
• Report Number: 1119421-2024-00523
• Device Sequence Number: 4479427
• Product Code: MJP
• UDI-Device Identifier: 00380652457323
• UDI-Public: 00380652457323
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2024

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: 02/21/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.170
• Device Lot Number: 15359738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/19/2024
• Date Device Manufactured: 02/23/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; MX60ET. 170; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female