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

Model Number	CCW0T4
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); Halo (2227)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, the patient did not able to obtain a consistent refraction, had a blinding and sometimes painful glare both day and night.The patient also experienced halos both inside and outside and had seen corneal specialists and retina specialist with no findings on exam.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
Additional information was provided in b.2., b.3., b.5., b.6., b.7., d.6.B, d.10.And h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received stating patient harm as blurred vision and significant glare.As per surgeon opinion iol caused or contributed to the event.The iol was exchanged for non company lens model 10 months 26 days following the initial implant procedure.The patient issues were not fully recovered but improving.Surgeons prognosis was optimistic.
Additional Manufacturer Narrative
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 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: 20427747
• Report Number: 1119421-2024-01999
• Device Sequence Number: 12727715
• Product Code: MJP
• UDI-Device Identifier: 00380652432962
• UDI-Public: (01)00380652432962(17)260723(11)220725(10)15454798(21)15454798021
• 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: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2024

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: 07/23/2026
• Device Model Number: CCW0T4
• Device Lot Number: 15454798
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 10/30/2024; 11/28/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/28/2024; 12/27/2024
• Date Device Manufactured: 07/25/2022
• 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: MONARCH II LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female