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

Model Number CNA0T0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blurred Vision (2137); Fibrosis (3167)

Event Type  Injury  

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

An ophthalmic surgeon reported that following a cataract extraction with an intraocular lens (iol) implant procedure, the patient had really bad anterior fibrosis on lens, nice large rhexis near the pupil and the fibrosis was good 2-3 mm inside of the rhexis.As per surgeon¿s prognosis, anterior capsule fibrosis affected vision.Patient¿s post operative bcva was 20/25 and 20/30.Patient was not hospitalized as a result of this event.Additional information was requested, but no further information is available.

Manufacturer Narrative

The product was not returned for analysis.Only photos were returned.One image was submitted for review.It is a broad parallelepiped of low-moderate magnification focused at the level of the intraocular lens.Significant anterior capsular on-growth is present 360 degrees.The central few millimeters remains clear.No root cause of the anterior capsular on-growth can be ascertained from the image.A second image (highly similar the first image) was submitted for review.It is a broad parallelepiped of low-moderate magnification focused at the level of the intraocular lens.Significant anterior capsular on-growth is present 360 degrees.The central few millimeters remain clear.No root cause of the anterior capsular on-growth can be ascertained from the image.The root cause for the reported complaint could not be determined.No root cause of the anterior capsular on-growth can be ascertained from the returned images.All product history records are quality reviewed prior to product release.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: 16050237
• MDR Text Key: 306152280
• Report Number: 9612169-2022-00722
• Device Sequence Number: 1
• Product Code: HQL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CNA0T0
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH II LOADING FORCEPS; PROVISC
• Patient Outcome(s): Other