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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient had glare, reduced contrast, fluctuating vision.The iol was exchanged for unspecified monofocal lens.Clinical reason for explant mentioned as mechanical complication.
Additional Manufacturer Narrative
The explanted lens was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if qualified products were used.The root cause cannot be determined for the reported complaint of "glare, reduced contrast, fluctuating vision, explant".Each lens is subjected to a 100% assessment of the power (cylinder and sphere) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The explanted lens was not returned for an evaluation.The reporter was the consumer.The consumer was advised to speak to surgeon regarding issues they are experiencing or seek a second opinion.Company is unable to provide medical advice or recommendations.Consumer was advised an investigation will be performed on the serial number of the implanted lens and if interested in the final response they may call back in 120 days for results.Consumer was asked to contact company should additional details become available.Patient educational materials were emailed.Information was provided that the company (1.50 cyl.) 16.0 diopter (add power +2.2/+3.2 diopter) was removed and replaced with an unspecified monofocal lens.The diopter information of the replacement was also not provided.Due to the exchange of multifocal toric lens for a monofocal lens, this suggests that the replacement lens (monofocal) may have been an improved choice for the patient vision needs.File will be reopened if new information or the sample is received.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: 20901507
• Report Number: 1119421-2024-02434
• Device Sequence Number: 14703412
• Product Code: MJP
• UDI-Device Identifier: 00380652457309
• UDI-Public: (01)00380652457309(17)260307(11)220309(10)15363896
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

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: 03/07/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.160
• Device Lot Number: 15363896
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/11/2024
• Date Device Manufactured: 03/09/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown