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

Model Number	CC60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-health care professional reported that after surgery, the patient went for the checkup and said that his vision was blurring out every 20 to 30 seconds, asked him to keep using the eye drops everything will clear up.Patient had a second independent exam and they said if your vision wasn't blurring in and out that would have 20/20, planned for lens replacement.There are two medical reports associated with this patient.This file belongs to left eye.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.Associated products were not provided.The root cause could not be determined for the patient¿s fluctuating vision.The lens remains implanted.Each lens is subjected to a 100 percent assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The company monofocal non-toric lens, which corrects for one distance, near or far, as targeted by the surgeon.The reporter was the patient.The patient indicated they have astigmatism.The patient was informed that the company lens does not have a cylinder component and does not correct for astigmatism.The reporter provided follow up information that they spoke with the implanting facility.The reporter stated the nurse informed them that they were offered lenses that allow near and far vision.Due to cost constraints, the patient selected standard lenses.Surgeon office unwilling to consult further with the patient.Patent may have lenses exchanged after the first of the year.File will be reopened if new information is received.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.

• Brand Name: CLAREON ASPHERIC UV ABSORBING IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 20585534
• Report Number: 1119421-2024-02139
• Device Sequence Number: 8575537
• Product Code: HQL
• UDI-Device Identifier: 00380652396776
• UDI-Public: (01)00380652396776(17)270422(11)230424(10)15639347
• 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
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2024

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 Model Number: CC60WF
• Device Lot Number: 15639347
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 11/01/2024
• Date Device Manufactured: 04/24/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male