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

Model Number	CNWTT4
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, at the time of implantation, the haptic did not spring out.The surgeon had to manipulate the haptic out during the same procedure.The procedure was completed on the same day, and the patient was transferred to the recovery room in good condition.Following the implant procedure, the patient experienced blurry vision.The iol was exchanged for the same model and same diopter toric lens from the same company 7 days after the initial implant procedure.The clinical reason for explant was reported as "iol had dislocated from initial implantation." additional information has been requested and received stated that the surgeon's prognosis was excellent and the patient was very happy.The patient's issue was resolved with no harm.
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 file indicates the use of a non-qualified delivery system.A viscoelastic was indicated that would be qualified with a quailed cartridge combination.The product investigation could not identify a root cause.The product was not returned for evaluation.The delivery system indicated is not qualified.The file indicates the haptic issue caused the lens to dislocate which caused the blurry vision.The lens was replaced with the same lens model and diopter.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• 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: 22112124
• Report Number: 1119421-2025-01536
• Device Sequence Number: 7063095
• Product Code: MJP
• UDI-Device Identifier: 00380652469128
• UDI-Public: (01)00380652469128(17)260607(11)220609(10)15428964
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2026
• Device Model Number: CNWTT4
• Device Catalogue Number: CNWTT4.230
• Device Lot Number: 15428964
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 08/01/2025
• Date Device Manufactured: 06/09/2022
• 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: DUOVISC VISCOELASTIC SYSTEM; INTREPID AUTOSERT IOL HANDPIECE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female