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	Visual Disturbances (2140); Halo (2227)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following the intraocular lens (iol) implant procedure, the patient complained of dysphotopsia.The lens was exchanged with another lens 9 months and 19 days after the initial implant procedure.The clinical reason was dysphotopsia.Additional information has been requested.
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).
Additional Manufacturer Narrative
Corrected information was provided in a.2.A.3 b.5.B.6.B.7.D.10.And h.6 (patient codes).Additional information was provided in h.11.The product was not returned.Product history records were reviewed, and the documentation indicated the product met release criteria.The account indicated the use of qualified associated products.The product investigation could not identify a root cause for the reported complaint.The product has not been received to evaluate.Each lens is subjected to a 100 percent assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the company (1.50cyl), 15.5 diopter (add power +2.2/+3.2) lens was replaced with a non-company, 15.0 diopter, multifocal lens model.Information was provided that the patient had pre-existing posterior vitreous detachment (pvd), dry eye syndrome (des), and meibomian gland dysfunction (mgd).No additional information has been provided at this time.File will be reopened when new information or the product is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Upon further review of initial reported information patient also experienced positive dysphotopsia, glare and halos.The lens was exchanged with non-company iol.There was no patient impact and patient issue was resolved.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The lens was returned for evaluation.Solution is dried on the lens.The lens is cut in half, typical of insertion and removal from the eye.A power and resolution inspection could not be conducted due to extensive damage.The product investigation could not identify a root cause for the reported complaint.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: 19927069
• Report Number: 1119421-2024-01536
• Device Sequence Number: 8375101
• Product Code: MJP
• UDI-Device Identifier: 00380652457293
• UDI-Public: 00380652457293
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2024

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: 05/02/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.155
• Device Lot Number: 15401571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 09/30/2024; 11/15/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/28/2024; 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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: DUOVISC VISCOELASTIC SYSTEM.; MONARCH II LOADING FORCEPS.; MONARCH III IOL, CARTRIDGE D.; MONARCH III IOL, INJECTOR.; ORA SYSTEM WITH VERIFEYE MESSAGING.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female