MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNA0T4
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that the lens had become cloudy only in the upper part, since the day after surgery.The sample was not available since it was still implanted in the patient's eye.Additional information has been requested and received stating that membrane treatment procedure was performed combined with the cataract surgery during the initial surgery but no gas or oil was used.The size of the ccc was larger than the pupil and ccc was not confirmed in the photograph.Vision was not bad as the clouding does not affect the pupil area.There were no plans to replace of iol or clean.Doctor's opinion: when viewed from the front, it was not as cloudy as it appears in the photograph, and the iol was clouded like a rainbow on the outside of the lens.It shines a little dimly, as if it were coated with oil.A chemical reaction due to contact with the oil or lubricant in the cartridge, friction, co2, etc.May have occurred.Additional information received stating that the findings of iol appear to have faded slightly one week later than the day after the surgery (improving).The patient's vision was not affected as of today, but the doctor seems to be concerned when observing with a slit.
Additional Manufacturer Narrative
Correction information has been provided in d.4.Additional information has been provided in h.3., h.6., and h.11.The product was not returned for analysis.Only photo was returned.This photo is of an pciol through a dilated eye.There appears to be a medium to dense opacification on the upper half of the iol but does not appear to be in the visual axis.Also, it appears the opacification is on the anterior surface of the lens but is difficult to be certain the location of the opacification.There is nothing distinctive enough to determine what is on the iol.This is a photograph of opacification on an iol of unknow origin.The root cause for the reported complaint could not be determined.Based on our observation on the returned photo, there appears to be a medium to dense opacification on the upper half of the iol but does not appear to be in the visual axis.Impact on the vision cannot be determined from the photos.A definitive determination of opacification cannot be made from the returned photos as there is nothing distinctive enough to determine what is on the iol.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM
• 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: 19748731
• Report Number: 9612169-2024-00698
• Device Sequence Number: 9016145
• Product Code: MJP
• UDI-Device Identifier: 00380652399227
• UDI-Public: (01)00380652399227(17)270419(11)230421(10)25619402
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNA0T4
• Device Lot Number: 25619402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 10/07/2024
• Date Device Manufactured: 04/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OPEGAN; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown