MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON TORIC UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCW0T3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient could not read signs after 9 feet and anything closer than 3 feet and feels imbalance of right eye.The imbalance was challenging.The doctor feels the implant and fit was correct.Additional information has been received that surgeon feels there was some improvement but patient was unable to read traffic signs, street signs.The patient feels the condition was same and the imbalance causes difficulty to walk into walls and to concentrate and read.The close up vision was worse than expected.The patient was using reading glasses for work.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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
Additional information has been provided in b.6.And d.10.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information provided in d.4.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC UV ABSORBING 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: 20127236
• Report Number: 9612169-2024-00852
• Device Sequence Number: 19649738
• Product Code: MJP
• UDI-Device Identifier: 00380652431637
• UDI-Public: (01)00380652431637(17)260611(11)220613(10)25429211(21)25429211145
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2024

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: 06/11/2026
• Device Model Number: CCW0T3
• Device Catalogue Number: CCW0T3.105
• Device Lot Number: 25429211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 10/03/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/03/2024; 10/30/2024
• Date Device Manufactured: 06/13/2022
• 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: AMVISC.; MONARCH II LOADING FORCEPS.; MONARCH III CARTRIDGE D.; MONARCH III INJECTOR.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Unknown