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

Model Number	CCWTT5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
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 consumer reported that after an intraocular lens (iol) implantation procedure, she had several concerns, a month later she had a yag surgery and the vision was worsened than before the surgery.Additional information was requested.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received from patient stating that physician was contacted as she still have the diminished eyesight in right eye especially.There was something causing obstructed vision in that eye.It¿s was not like a foreign object.Patient do have lasik scheduled for next month.
Additional Manufacturer Narrative
Additional information was added 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.Associated product information was not provided.The product investigation could not identify a root cause for the reported complaint.The product was not returned.The reporter was the patient.Patient indicated a yag was conducted, but the reason was not provided.Patient indicated they are scheduled for future lasik.There has been no response from the impaling facility to the request for follow-up information.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was added in b.5., b.6., b.7.And d.10.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stating that the patient was educated that rings & halos will be noticeable around lights due to lens design.Patient elected to proceed with lens with the understanding that rings and halos remain around lights at night.

• 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: 19642744
• Report Number: 1119421-2024-01232
• Device Sequence Number: 12549284
• Product Code: MJP
• UDI-Device Identifier: 00380652458481
• UDI-Public: (01)00380652458481(17)260501(11)220503(10)15401628(21)15401628041
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/22/2024

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: 05/01/2026
• Device Model Number: CCWTT5
• Device Catalogue Number: CCWTT5.220
• Device Lot Number: 15401628
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 07/10/2024; 08/20/2024; 09/24/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/07/2024; 09/12/2024; 10/22/2024
• Date Device Manufactured: 05/03/2022
• 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: AMVISC.; CLAREON MONARCH IV IOL INJECTOR.; MONARCH II LOADING FORCEPS.; MONARCH III IOL CARTRIDGE D.; ORA SYSTEM WITH VERIFEYE MESSAGING, CART.; ORA SYSTEM WITH VERIFEYE MESSAGING.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female