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 Code	Blurred Vision (2137)
Date of Event	12/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that, after intraocular lens implantation surgery, the patient experienced blurred vision.Hence the lens was explanted and replaced with another lens in a secondary procedure.The clinical reason for explant was hyperopic/results higher diopter needed.
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
Additional information was received stating that, the cause of the issue is due to master calculations inaccurate.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated a qualified associated cartridge and handpiece with an unspecified viscoelastic.Information was provided that the event was related to the patient's prior s/p lasik surgery and the intraocular lens (iol) master calculation being inaccurate.The information indicates the event is most likely related to a calculation error.Based on the information provided, the event does not appear to be related to the product.Additional information was provided that the 18.0 diopter (add power +2.2/+3.2) lens was replaced with a 19.5 diopter (add power +2.2/+3.2) lens.The account indicated the product was not available to evaluate.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.The exchange for a 1.5 higher diopter difference of the same lens model may suggest that the replacement lens was an improved choice for the patient's vision needs.No further information has been provided at this time.File will be reopened when 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: 18516623
• Report Number: 1119421-2024-00106
• Device Sequence Number: 17825615
• Product Code: MFK
• UDI-Device Identifier: 00380652408080
• UDI-Public: 00380652408080
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

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: 08/02/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.180
• Device Lot Number: 15455987
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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: CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC IOL; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female