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	Dry Eye(s) (1814); Visual Impairment (2138)
Date of Event	11/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A surgeon reported that following an intraocular lens (iol) implant procedure, right vision after surgery was in 20/50-20/60 range with refraction of plano -1.25 x 115 (repeated 4 times at 4 separate visits over the span of 2 months).The patient had issues with dry eye syndrome and this was treated more aggressively after surgery than before (also the reason for the number of post op visits).The surgeon looked at trying to fix the astigmatism that remained but astigmatismfix.Com showed that the iol power was not strong enough for a rotation of the axis to work.Repeat measurements were then done and showed that a company lens 18.5d at 012 degrees should be the lens of choice.Additional information has been requested.
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).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that a qualified cartridge, handpiece, and viscoelastic were used.The product investigation could not identify a root cause for the reported complaint.The product was not returned.The complaint was received through expert opinion doctor of medicine (eomd).Each lens is subjected to a 100 percentage (%) assessment of the power (cylinder and diopter) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Follow up attempts were made for additional information.No further information has been provided.If the lens or additional information becomes available, the file will be reopened and updated.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: 18892142
• Report Number: 1119421-2024-00458
• Device Sequence Number: 20366163
• Product Code: MJP
• UDI-Device Identifier: 00380652457378
• UDI-Public: 00380652457378
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2024

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: 04/27/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.195
• Device Lot Number: 15392768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• 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 MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male