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); Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned.The product history and batch records were reviewed and documentation indicated the product met release criteria.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 that during an intraocular lens (iol) implant procedure, a foreign material was found on the surface of the optic during implantation.The foreign material was unable to be removed using irrigation aspiration.The lens remains implanted.No patient harm reported.The surgeon considers that the foreign material may be caused by the cartridge.Additional information has been requested.

Manufacturer Narrative

The cartridge was not returned.Fifteen unopened cartridges for the same lot were returned.All fifteen returned unopened cartridges were evaluated.The returned unopened cartridges were microscopically examined with no damage observed.No particulate was observed inside the cartridge.The cartridges were functionally tested per the directions for use (dfu) using qualified associated products.No lens or cartridge damage was observed after the lens deliveries.No foreign material was observed.The fifteen cartridges were cleaned for further evaluation.Top coat due stain testing was conducted with acceptable results.A video was provided.The lens and cartridge preparation are not shown.The cartridge tip comes into view as it is inserted into the incision.The lens is rapidly advanced into the eye.The haptics appears to be in acceptable positions tucked in the fold.As the lens unfolds, an area that appears to be lens damage is observed on the posterior surface of the optic near the trailing edge.This may have been interpreted as foreign material.The area is manipulated with a metal tip with no movement observed.Qualified associated products were indicated.The root cause for the reported complaint could not be determined.The used cartridge complaint sample was not returned.No determination can be made without physical evaluation of the complaint sample.Based on review of the provided video, the area in question had the appearance of lens damage.This could not be verified, as the lens remains implanted.Functional testing was conducted with the fifteen returned unopened cartridge samples for the reported lot number.No lens or cartridge damage was observed after the lens deliveries.No foreign material was observed.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: 11020286
• MDR Text Key: 222639627
• Report Number: 1119421-2020-01951
• 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: foreign,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: 15032284
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 02/20/2021; 03/03/2021
• Supplement Dates FDA Received: 03/01/2021; 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL INJECTOR; PANOPTIX TORIC IOL; PROVISC