MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. 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 Disturbances (2140)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A non health care professional reported that following an intraocular lens (iol) implant procedure, the patient experienced dark and blurry vision.Clinical reason being mentioned as above less than glaucoma stage not following optimal lens function.The iol was explanted and exchanged for an unknown toric lens in the secondary implant procedure.Additional information has been requested.There are two medical reports associated with same event.This file is 2 of 2.
Additional Manufacturer Narrative
Correction information has been provided in b.2, b5 and h.11.Based on internal review following submission of the initial report, this event does not meet criteria for reporting as a serious injury.No further reports required.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received it stated that explanted iol in the patient with advanced glaucoma stage, not allowing optimal lens function.Clinical reason mentioned as vision dark and blurry.

• Brand Name: CLAREON TORIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22002612
• Report Number: 9612169-2025-01028
• Device Sequence Number: 9115029
• Product Code: MJP
• UDI-Device Identifier: 00380652410014
• UDI-Public: (01)00380652410014(17)270812(11)230814(10)25692938
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: CNW0T4
• Device Lot Number: 25692938
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/11/2025
• Date Device Manufactured: 08/14/2023
• 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: UNSPECIFIED TORIC LENS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown