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 No Consequences Or Impact To Patient (2199)

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

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.The root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported that during an intraocular implantation procedure fibrous material was present on the posterior side of the intraocular lens (iol).The surgeon believes it is coming from the cartridge.The fibrous material was removed at the time of the initial procedure with an irrigation/ aspiration handpiece.There was no patient harm.Further information is not available from the healthcare professional for this report.

Manufacturer Narrative

Additional information has been provided in h.3, h.6 and h.10.The cartridge was not returned.Two photos were provided, which show the same image of an implanted multifocal lens.A foreign material is observed to the left of the irrigation/aspiration tip.The product investigation could not identify a root cause for the reported material.The cartridge was not returned.No determination can be made without physical evaluation of the complaint sample.Two photos were provided, which show the same image of an implanted multifocal lens.The lens model/diopter, handpiece and viscoelastic used were not provided.It is unknown if qualified products were used.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: 10631255
• MDR Text Key: 210605469
• Report Number: 1119421-2020-01386
• 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
• Report Date: 12/14/2020

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: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: I/A HANDPIECE.; UNSPECIFIED IOL.