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

Model Number	CNW0T3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Eye Pain (4467)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product 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 "explant, upset with vision, eye feels heavy, could not tolerate distance needing for reading".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.Based on the information provided, the event may not be related to the product.An intraocular lens (iol) exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.The company (1.50 cylinder) 19.5 diopter lens was removed and replaced with a company (1.50 cylinder) 22.5 diopter lens.This information of a three diopter difference with the replacement lens would indicate that the diopter of the replacement lens was an improved selection for this patient's vision needs.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following the intraocular lens (iol) implant procedure, the patient was upset with vision and felt eye heaviness and could not tolerate distance vision for reading.The lens was exchanged for an unknown lens model 8 months after the initial implant procedure.Clinical reason for explant was mentioned as mechanical complications of iol.Additional information has been requested.
Additional Manufacturer Narrative
The manufacturer internal reference number is:(b)(4).
Event or Problem Description
Additional information received stating that there was no patient harm.As per surgeons opinion product not contributed to event.Patient's outcome was recovered.

• 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: 19869874
• Report Number: 1119421-2024-01460
• Device Sequence Number: 7675729
• Product Code: MJP
• UDI-Device Identifier: 00380652409667
• UDI-Public: (01)00380652409667(17)260823(11)220825(10)15462769
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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: 08/23/2026
• Device Model Number: CNW0T3
• Device Lot Number: 15462769
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 08/23/2024
• Date Device Manufactured: 08/25/2022
• 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 TORIC IOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown