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

Model Number CNA0T0

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2023

Event Type  malfunction  

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.Photo review: photo showing an implanted iol, a dark mark can b seen on the optic near the haptic.The manufacturer internal reference number is: (b)(4).

Event Description

A non healthcare professional reported that a square foreign material was found attached to the root of the iol after iol insertion.There was no patient harm reported.Additional information has been received includes that scratch was noticed at the root of the lens and was tried to remove with aspiration during the surgery.It has not become smaller or disappeared one week after the surgery.The surgeon suspects that the base of the iol may be peeling off.

Manufacturer Narrative

The device was returned loose in a plastic bag.The lock-out assembly has been removed.Viscoelastic is dried in the device.The plunger has been fully advanced outside the nozzle tip.No damage observed.No lens returned.No root cause identified as no iol was returned for evaluation, only the device was returned and no damage was found on the device.Based on these investigation findings and the lack of sample, we are unable to determine a root cause for the reported complaint.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 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: 17816156
• MDR Text Key: 324221953
• Report Number: 9612169-2023-00674
• 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
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• 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: 25517151
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HYALURONATE NA 0.82 OVS 1.0%.
• Patient Age: 83 YR
• Patient Sex: Female