MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Catalog Number 8065977763

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned for analysis.Complaint history and product history records could not be reviewed because the reporting facility 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).

Event Description

A nurse reported, they are seeing curly strings of plastic in the eye that the surgeon has to pull out following intraocular lens implantation procedures.The site suspects the cartridge as the string occurs in the same spot each time.Additional information is requested.

Manufacturer Narrative

The cartridge was not returned for evaluation.The lot number was not provided.Six potential lot numbers were provided for stock on hand at the reporting facility.None could be verified to be the reported complaint lot.Complaint history and product history records were reviewed for the potential lots and documentation indicated the products met release criteria.The associated lens model is qualified.It is unknown if the lens was in the qualified diopter range.The handpiece and viscoelastic used were not provided.It is unknown if qualified products were used.The root cause for the reported event cannot be determined.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The previous report submitted for this event contained an error in h.1.- ¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11047231
• MDR Text Key: 223586269
• Report Number: 1119421-2020-01980
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 02/16/2021; 03/03/2021
• Supplement Dates FDA Received: 03/03/2021; 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ PANOPTIX TRIFOCAL IOL; TFNT00, UNSPECIFIED AS IQ PANOPTIX NATURAL, TFNT00