MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number MA60MA

Device Problem Material Opacification (1426)

Patient Problem Insufficient Information (4580)

Event Date 06/30/2022

Event Type  malfunction  

Event Description

A nurse reported that following the cataract surgery with intraocular lens implant procedure found to have deposits on the lens.In the surgeon¿s opinion the cause of the event was the patient has had a high proportion of mercury and aluminum and lead in the blood.The patient also had blood washing (plasmapheresis) in (b)(6) 2022.Additional information has been requested and received stating the patient had decided for a planned explant in the coming month.The diagnosis was lens opacification.There are two medical device reports associated with this patient.This report is for the left eye.Additional information received and stated that, iol explantation was planned.

Manufacturer Narrative

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

Manufacturer Narrative

The product investigation could not identify a root cause for the reported complaint.Not enough information was provided by the reporter for further investigation.Information was provided that the lens was implanted on (b)(6) 2000.In the opinion of the surgeon, what are the causes of the event? pat.Has had a high proportion of mercury and aluminum + lead in the blood.(b)(6) 2022 patient had plasmapheresis.No further information has been provided.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received and stated that the secondary surgery took place on (b)(6) 2022.

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15887426
• MDR Text Key: 307701802
• Report Number: 1119421-2022-02529
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MA60MA
• Device Catalogue Number: MA60MA.XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2023
• 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
• Patient Sex: Male