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 Problems Contamination (1120); Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 01/08/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported an intraocular lens (iol), with a chip in it.The procedure was completed the same day.Additional information was provided by a nurse, that the lenses were not chipped upon opening.The chip is found after the lens has been loaded into cartridges, and is unsure if event occurred upon insertion or not.The nurse looked at the cartridge under the microscope and found irregularities within the inside of the cartridge and feels that this is causing the issue.Further information was provided by the nurse describing the iol as having more of a hole in it.The iol was exchanged during the initial procedure.

Manufacturer Narrative

Product evaluation: the product was not returned.The customer indicated the use of non-qualified products.The root cause is most likely related to a failure to follow the directions for use (dfu).The account used an unqualified lens/cartridge combination.The use of non-qualified combinations may result in delivery issues and/or damage.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: 9667175
• MDR Text Key: 181930901
• Report Number: 1119421-2020-00184
• 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,other
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

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: 32740263
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 03/18/2020
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SA60AT.255, ACRYSOF SP FOLDABLE 6.0 OPTIC, HWV.