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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body Sensation in Eye (1869)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: 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 surgeon reported that during an intraocular (iol) implant procedure, a clear "strip" of foreign material was noted on the posterior aspect of the iol optic once implanted in the patient's eye.The surgeon used forceps and was able to remove the foreign material.The material seems not to cause any irritation, inflammation, or other issues for patient.Initially, he thought it was a piece of cortex or lens material that got transferred into the eye as the lens traversed the primary incision.However, it seems to be related to the cartridge.We visually inspected the lens prior to implantation to ensure it's not a lens issue, and it is not present.

Manufacturer Narrative

A used company iii (d) cartridge was returned.Viscoelastic is dried in the cartridge.A small aneurysm is observed on the bottom of the tip in the center.Tip stress was also observed.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The returned specimen cup was sent to the ftw particle lab for evaluation.The solution from the specimen cup was visually and microscopically examined.The contents of the specimen cup were poured into a pre-clean petri dish.Microscopic examination showed a clear natural appearing fiber approximately 730 ¿m in length.The clear fiber was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the fibers generated spectra to a library of spectra found the best match to be wypall fibers (paper).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.The root cause for the reported foreign material could not be determined.The returned foreign material was evaluated by the ftw particle lab.Microscopic examination showed a clear natural appearing fiber approximately 730 ¿m in length.The clear fiber was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the fibers generated spectra to a library of spectra found the best match to be wypall fibers (paper).The return company iii (d) cartridge was evaluated.No fibers were observed.Top coat dye stain testing was conducted with acceptable results.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: 11423761
• MDR Text Key: 244411391
• Report Number: 1119421-2021-00493
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 380659777639
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2021

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?: Yes
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 03/03/2021; 03/18/2021
• Supplement Dates FDA Received: 03/18/2021; 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUOVISC VISCOELASTIC SYSTEM.; FORCEPS.; INTREPID AUTOSERT IOL HANDPIECE.
• Patient Age: 73 YR