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

Model Number	CCWTT4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Blurred Vision (2137); Visual Impairment (2138)
Date of Event	07/22/2024
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-health care professional reported that following an intraocular lens (iol) implant procedure, the patient experienced with blurred vision and does not want glasses.The lens was exchanged for another lens model 03 months 07 days following the initial procedure.Clinical reason for explant was mentioned as refraction result myopia with astigmatism.Additional information has been requested.
Event or Problem Description
Additional information was received, optical biometry and the ora were consistent and in agreement but she was left with myopia and residual astigmatism.Thought this might have been due to a higher than average surgical induced astigmatism from the cataract wound even though the wound was well constructed.There was greater than normal corneal edema which took 2 months to resolve completely especially at the wound.There was no patient harm.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).

• 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: 20755693
• Report Number: 1119421-2024-02286
• Device Sequence Number: 15826022
• Product Code: MJP
• UDI-Device Identifier: 00380652457958
• UDI-Public: (01)00380652457958(17)270419(11)230421(10)15636411
• 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: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2024

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 Model Number: CCWTT4
• Device Catalogue Number: CCWTT4.220
• Device Lot Number: 15636411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/24/2024
• Date Device Manufactured: 04/21/2023
• 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 WITH VERIFEYE MESSAGING.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female