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

Model Number	CNWTT3
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history records were reviewed, and documentation indicated the product met release criteria.Root cause has not been identified.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.
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens implantation procedure, the intraocular lens had a huge crack or scratch across the center.The tech did have issues with 3 other lenses that day but it was her confidence in loading the lenses that caused the issues.The lens was extracted from the eye and a new lens was inserted with no further issues.Additional information has been requested.There are three medical device reports associated with this report.This is 2 of 3.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of a qualified associated cartridge and handpiece with a non qualified viscoelastic.The root cause for the reported complaint may be related to a failure to follow the ifu.The viscoelastic indicated is not qualified for the lens or company model combination used.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The account indicated the product remained in the patient's eye.Information was provided that a facility representative reported they were not sure if the tech was at fault or if there was a manufacturer defect.The reporter provided that tech did have issues with 3 other lenses that day but it was the techs confidence in loading the lenses that caused the issues.Due diligence has been performed in an attempt to obtain further information on this event.The reporter has not responded to requests for follow up information.File will be reopened if new information is received.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 RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21603876
• Report Number: 1119421-2025-00677
• Device Sequence Number: 14560458
• Product Code: MJP
• UDI-Device Identifier: 00380652468527
• UDI-Public: (01)00380652468527(17)280708(11)240710(10)15885823
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNWTT3
• Device Catalogue Number: CNWTT3.195
• Device Lot Number: 15885823
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 05/08/2025
• Date Device Manufactured: 07/10/2024
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; HEALON OVD; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Patient Sex: Unknown