MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	CNA0T0
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	10/01/2024
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 right eye started to have a needle in eye but at 2:40 am.The patient started to see an "x" in each luminous point, which persists to this day on (b)(6) 2024).This was very disturbing, and i never drove at night again.However, doing tests today on (b)(6) 2024) in sunlight, the patient noticed that the problem has decreased.Even under good lighting, the light color no longer "pops" and patient started to see the white less bluish and closer to the white really.In the lens of the right eye this did not occur.The ophthalmologist asked for the lenses to be zeroed away.On the right, patient see better up close and worse far away.The patient notice that there was a small delay for adjusting the vision, when there was a rapid variation of focus (far/near or left/right).The patient believed this is normal because nothing fully replaces the lens.The patient also stated, do not know if the brain will correct this over time.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• 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: 20680775
• Report Number: 9612169-2024-01167
• Device Sequence Number: 15592801
• Product Code: HQL
• UDI-Device Identifier: 00380652396462
• UDI-Public: (01)00380652396462(17)270209(11)240211(10)25801231
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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: CNA0T0
• Device Lot Number: 25801231
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 11/14/2024
• Date Device Manufactured: 02/11/2024
• 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: Other
• Patient Age: 74 YR
• Patient Sex: Unknown