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 Code	Visual Impairment (2138)
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 healthcare professional reported that the patient had -1.25d miss after the implantation of the intraocular lens.The patient showed no remarkable ocular pathology prior to surgery, including no dry eye syndrome (des), corneal or retinal issue of any kind.One month post operatively, the patient showed two lines loss in best-corrected visual acuity (bcva).The surgeon noted that there were no abnormalities during the surgery.When analyzing the surgical images, there was nothing notable that stands out.The surgeon had good variable control throughout each capture, aside from a single small bubble present and possible endothelial cells in the fringe pattern.All images were extremely consistent.There were no errors for any measurements or data as compared to the testing results.Post operatively, there was no corneal or retinal pathology present.The eye was quiet without any flare and the patient has no dry eye syndrome symptoms.Sine there was no obvious error contributing to the refractive miss, the surgeon will wait to proceed with a possible lens exchange until all additional testing evaluations and consultations are completed.

• 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: 17198161
• Report Number: 1119421-2023-01165
• Device Sequence Number: 20507000
• Product Code: MJP
• UDI-Device Identifier: 00380652457996
• UDI-Public: 00380652457996
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/24/2024
• Device Model Number: CCWTT4
• Device Catalogue Number: CCWTT4.240
• Device Lot Number: 15236818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• 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: Other
• Patient Sex: Female