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

Model Number CNA0T0

Device Problem Material Frayed (1262)

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

Event Type  malfunction  

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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, a defect on the periphery noted upon implanting lens.The surgeon did leave the lens in the patient with no patient harm.The proper loading procedure was followed.The surgeon did mention that the way see the lens in the eye was the way it delivered.She never rotated it which would put the scratch on the right side as the lens was implanted.Additional information has been requested.

Manufacturer Narrative

Only photo was returned.The received photo shows an implanted iol on a monitor screen, there appears to be a dark line near the edge of the optic and a dark spot in the middle of the optic.The exact location of the line/spot cannot be confirmed.A definitive determination of the reported damage cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.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: 13003275
• MDR Text Key: 282335500
• Report Number: 9612169-2021-00293
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652393737
• UDI-Public: 00380652393737
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: CNA0T0
• Device Lot Number: 25185011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1