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

Model Number CNA0T0

Device Problems Material Discolored (1170); Device Contamination with Chemical or Other Material (2944)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2023

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that following an intraocular lens (iol) implant procedure, at the 1-month postoperative visit, no foreign material was observed.There is no loss of vision, and the patient has no complaints.The patient had no systemic disease.At the 3-month postoperative visit, it was confirmed that there was a fibrin-like foreign material was found adhered on the surface of the iol.There's no patient harm.

Manufacturer Narrative

The product was not returned for analysis.Only photo was returned.The reporting facility did not provide a lot number or any identification of the product.Photo shows a patient's eye.White in appearance marks are visible over the pupil.No determination can be made from the photos."at the 3-month postoperative visit, it was confirmed that there was a fibrin-like foreign material on the surface of the iol.At the 1-month postoperative visit, no foreign material was observed.There is no loss of vision, and the patient has no complaints.The patient had no systemic disease".Based on our observation of the attached photo, white in appearance marks are visible over the pupil.No determination of the reported complaint can be made from the returned photo and without the evaluation of the physical sample.A final root cause cannot be determined based on available information.All product history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received and stated there were deposits, inflammatory materials adhering to the surface of the iol, but the pupillary area was not affected and the patient has no subjective symptoms.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The file was reopened as new information was received; it was confirmed that the lens was not explanted.Serial number was also provided."it was confirmed as the translation error of the questionnaire.So the attachment was corrected and re-attached.Regarding to this case, iol was not explanted"."deposits are seen on the surface of the iol, but the pupillary area is not affected and the patient has no subjective symptoms".The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM
• Type of Device: 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: 18040530
• MDR Text Key: 326982432
• Report Number: 9612169-2023-00762
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNA0T0
• Device Lot Number: 25263097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Male