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

Model Number	CCWTT3
Medical Device Problem Code	Application Program Problem: Power Calculation Error (1473)
Health Effect - Clinical Codes	Visual Impairment (2138); Dizziness (2194)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device 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 physician reported that following an intraocular lens (iol) implant procedure, the patient balance is off due to flipped axis astigmatism.The iol was exchanged for another lens model 14 days following the initial implant procedure.The clinical reason for explant mentioned as overcorrected astigmatism causing anisometropia.Additional information has been received from the physician, a patient iol calcs had 0.9 cyl, topography 1.4, and ora showed between 1.24 and 1.64, all between 85-95 degrees.The patient iol is at 95, but she has between 0.75 and 1.00 and they look in the phoropter at 170.Meaning the t3 surgeon put in completely flipped patient axis.Additional information has been received and surgeon has mentioned about the prognosis as dizziness due to flipped astigmatism corrected by changing the astigmatism by 90 degrees.

• 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: 17797627
• Report Number: 1119421-2023-01642
• Device Sequence Number: 5761902
• Product Code: MJP
• UDI-Device Identifier: 00380652457422
• UDI-Public: 00380652457422
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2023

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: 07/09/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.220
• Device Lot Number: 15450266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• 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: ORA SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown