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

Model Number	CNW0T5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported following an intraocular lens (iol) implant procedure, the patient experienced fuzzy vision and bright light sensitivity.The iol was exchanged for another lens 7 days following the initial procedure.Clinical reason for explant mentioned as target axis 165 degrees.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
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received that there was no patient harm.The surgeon plan to rotate the post replacement.
Additional Manufacturer Narrative
Corrected information provided in b.2.And h.6.Additional information 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 a viscoelastic that is qualified for use with this lens, with the use of qualified lens/cartridge combinations.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% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the company lens 19.5 diopter lens was replaced with a company lens, 18.0 diopter lens.The difference in cylinder between the original implant lens model and the replacement lens model , as well as, an exchange to a 1.5 lower diopter, may suggest that the replacement lens model was an improved choice for the patient's vision needs.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).

• 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: 20890519
• Report Number: 1119421-2024-02419
• Device Sequence Number: 18103615
• Product Code: MJP
• UDI-Device Identifier: 00380652410649
• UDI-Public: (01)00380652410649(17)260522(11)220524(10)15417621
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2025

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: 05/22/2026
• Device Model Number: CNW0T5
• Device Lot Number: 15417621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 11/26/2024; 01/16/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 12/24/2024; 02/10/2025
• Date Device Manufactured: 05/24/2022
• 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; MONARCH II LOADING FORCEPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown