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
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.
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, on the left eye, in the presence of a strong point of light, started to see a luminous beam refracted in the colors of the rainbow, similar to a compass needle (thin at the tips and the width of the luminous point in the center) at the clockwise position of 3h:50m.The first time the patient drove at night it was terrible, because the light of each pole or sign presented this luminous beam.Even in the restaurant, every point of light presented this beam.The patient thought it could be a problem with the surgery.This was very disturbing and the patient never drove at night again.After surgery of the left eye, under strong light such as the sun, or even in a well-lit internal environment, the luminosity of what was seen was much higher than before with the lens.The patient started to see the excessively white, bursting the light color and tending to bluish.It was as if the color temperature of the white i saw was close to 5,500 degrees kelvin.The patient even thought about suggesting to company that a filter be placed on the lenses, lowering at least 100 degrees kelvin in what you see with them, so that the luminosity is closer to what was seen before.However, doing tests 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 the patient started to see the white less bluish and closer to the white really.The ophthalmologist asked for the lenses to be zeroed away.With a left view the patient see well far away and not so well close, which matches what was requested.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 believe this was normal because nothing fully replaces the lens.The patient also did not know if the brain will correct this over 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: 20680705
• Report Number: 9612169-2024-01166
• Device Sequence Number: 7217668
• Product Code: HQL
• UDI-Device Identifier: 00380652396455
• UDI-Public: (01)00380652396455(17)261016(11)231018(10)25733362
• 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: 25733362
• 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: 10/18/2023
• 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: Other
• Patient Age: 74 YR
• Patient Sex: Unknown