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 Insufficient Information (4580)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

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 that during an intraocular lens (iol) implant procedure, a foreign white solid material adhered to the surface of the optic during implantation.The foreign material was removed using irrigation aspiration.No patient harm reported.Additional information has been received states the surgeon considered that the foreign material was caused by the cartridge.

Manufacturer Narrative

The complaint cartridge was not returned.Three unopened cartridges for the lot were returned loose.All three 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 a qualified associated products.No lens or cartridge damage was observed after the lens deliveries.No foreign material was observed.The three cartridges were cleaned for further evaluation.Top coat due stain testing was conducted with acceptable results.A video was provided.The cartridge preparation and lens loading are not shown.The cartridge tip comes into view as it was inserted into the incision.The lens was rapidly advanced into the eye.The haptic positions appear to be acceptable, tucked in the optic fold.As the plunger is removed, a white piece of material is observed on the outside edge of the trailing haptic.As the haptic unfolds, the loose material is moved to the right side of the lens.The material is removed with the irrigation/aspiration (i/a) tip.The lens remains implanted.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.Functional testing was conducted with the three returned unopened samples for the reported lot number.No damage or foreign material was observed.Dye stain testing was conducted with acceptable results.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: 11012542
• MDR Text Key: 222016747
• Report Number: 1119421-2020-01924
• 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
• Report Date: 02/25/2021

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: 32761724
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Manufacturer Received: 11/22/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL DELIVERY SYS.; PROVISC.; SN6AT6.