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 Code	Blurred Vision (2137)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that after intraocular lens (iol) implantation, the patient experienced blurry vision.The lens was removed and replaced with another lens in a secondary procedure.The clinical reason for explant was mechanical complication.Additional information was requested, but no further information is available.
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.The product investigation could not identify a root cause for the reported complaint.Each lens is subjected to a 100% 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), 20.0 diopter (add power +2.2/+3.2) lens was replaced with an unspecified advanced technology intraocular lens (atiol) model.The product has not been received to evaluate.Follow up attempts were made.No further 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).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received stating surgeon's opinion, product cause or contribute to the event.The patient's issues resolved.The surgeon's prognosis was patient has met visual needs.
Additional Manufacturer Narrative
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 a qualified associated cartridge and viscoelastic with an unspecified handpiece.The product investigation could not identify a root cause for the reported complaint of blurry vision.The product has not been received to evaluate.Each lens is subjected to a 100 percentage 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), 20.0 diopter (add power +2.2/+3.2) lens was replaced with an unspecified advanced technology intraocular lenses (atiol) model.Additional information was provided that the patient had pre-existing mild age-related macular degeneration and anterior basement membrane corneal dystrophy.Follow up attempts were made.No further 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: 18729622
• Report Number: 1119421-2024-00295
• Device Sequence Number: 8107934
• Product Code: MJP
• UDI-Device Identifier: 00380652402309
• UDI-Public: (01)00380652402309(17)270515(11)230517(10)15645538
• 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: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/12/2025

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 Model Number: CNW0T3
• Device Lot Number: 15645538
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 03/18/2024; 12/10/2024; 01/17/2025
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 04/16/2024; 01/03/2025; 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; UNKNOWN HANDPEICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown