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

Model Number	CNW0T4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	03/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported following an intraocular lens (iol) implant procedure, the patient experienced blurry vision.The patient underwent salzman's module irrigation and cylindrical new surface post-corneal resurfacing.Additional information has been received and stated that patient had salzman's module that was thought to be insignificant but proved to greatly affect cylinder and spherical power measurements.Patient was significantly out of focus with initial lens implant cornea was resurfaced and allowed to heal.The lens was explanted and replaced with company lens in a secondary procedure.
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
Additional information was provided in h.3., h.6.And h.11.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 root cause cannot be determined for the reported complaint of blurry vision.Each lens is subjected to a 100percentage assessment of the power (sphere and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The completed questionnaire indicated that the sample was explanted, cut into five pieces, and discarded.The sample is not returning.The questionnaire indicated that the patient had salzman's nodule prior to surgery that was thought to be insignificant but proved to greatly affect cylinder and spherical power measurements.The patient was significantly out of focus with initial lens implant cornea was resurfaced and allowed to heal and then refraction using berdel iol formula.The company model 2.25 cylinder 16.5 diopter lens was removed and replaced with a company model 1.50 cylinder) 17.5 diopter lens.The patient is very happy with resurfacing cornea and iol exchange per the questionnaire (20/10 uncorrected) this information would suggest that the replacement lens model and diopter was an improved selection for this patient.Based on the combined information that a salzman's nodule was present on the cornea prior to surgery and the exchange for a different toric lens model with a larger diopter may suggest that the event may be related to the patient condition of the pre existing salzman's nodule, and unrelated to the iol.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC 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: 19296560
• Report Number: 1119421-2024-00916
• Device Sequence Number: 5855453
• Product Code: MJP
• UDI-Device Identifier: 00380652410090
• UDI-Public: 00380652410090
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/18/2024

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: CNW0T4
• Device Lot Number: 15663993
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 74 YR
• Patient Sex: Female