MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL; INTRAOCULAR LENS

Model Number SY60WF

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

Patient Problem Insufficient Information (4580)

Event Date 12/07/2023

Event Type  malfunction  

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, foreign substance on the posterior side of the iol was observed.Implant with this linear foreign debris seriously stuck won¿t come off with irrigation/aspiration (i/a) and on one of them had to use a lester hook to release.Additional information was requested.There are three medical device reports associated with this complaint.This report is 3 of 3.

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).

Manufacturer Narrative

The product was not returned for analysis.The reporting facility did not provide a lot number or any identification of the product.Photo provided shows an implanted iol on a monitor screen.There appears to be foreign material present on the optic.Based on our observation of the attached photo, the appears to be foreign material on the optic.A definitive determination cannot be made without the evaluation of the physical product.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).

• Brand Name: CLAREON IOL
• 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: 18426209
• MDR Text Key: 331906393
• Report Number: 9612169-2024-00012
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY60WF
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• 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