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	Vitreous Floaters (1866); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Posterior Capsule Opacification (4807)
Date of Event	03/11/2024
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 that following an intraocular lens (iol) implant procedure, the patient experienced blurry vision and glare from street lights and headlights.The patient was unable to drive at night.The surgeon was unsure of cause and symptoms and said lens was positioned properly.The patient was trying drops for dry eye and new glasses for improved vision.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if a qualified viscoelastic was used.The product investigation could not identify a root cause for the reported complaint.The product was not returned.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.Information was provided that the company 19.0 diopter (add power +2.2/+3.2) lens was replaced with an unspecified monofocal lens.The patient indicated their vision is now 20/20.The hcp office stated the hospital is not allowed to send explanted lens back since it has been implanted in the body.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received that the lens was explanted following the initial procedure.
Event or Problem Description
Additional information received that after the lens implant the patient experienced halos at night and have mild light sensitivity.The patient still cannot see properly and her vision was foggy and cloudy.She also experienced glare.The patient was using glasses for distances.The lens was well centered and had minimal posterior capsular opacification.The patient had keratoconjunctivitis.The lens exchanged with company monofocal lens.The symptoms has been resolved and the patient was doing good.
Additional Manufacturer Narrative
Correction information has been provided in d.4.Additional information provided in a.2., b.5., b.6., b.7., h.3., h.6.And h.11.Hcp (healthcare professional ) notes indicated that the patient was unable to tolerate the vision quality with the company iol.The replacement was a standard iol for distance.Patient was very happy at this point and already sees a big improvement.File will be reopened if new information is received.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: 19310156
• Report Number: 1119421-2024-00929
• Device Sequence Number: 16919589
• Product Code: MFK
• UDI-Device Identifier: 00380652408103
• UDI-Public: (01)00380652408103(17)250220(11)210929(10)15269981(21)15269981073
• 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: 2024
• 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): 10/11/2024

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: 02/20/2025
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.190
• Device Lot Number: 15269981
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 06/17/2024; 09/12/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 07/15/2024; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DISCOVISC.; MONARCH CARTRIDGE C.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female