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 Material Protrusion/Extrusion (2979); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

A sample product was not returned for analysis.Product history records were reviewed and documentation indicates the product met release criteria.The iol product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.There are 6 other complaints in the lot.Additional information was requested.(b)(4).

Event Description

A technician reported that during an intraocular lens (iol) implant procedure, the tip of the cartridge split as the lens was being ejected out.The surgeon was able to pull the cartridge out of the eye with the lens still partially sticking out.The iol was removed without any damage.The lens was reloaded into another cartridge and implanted successfully.Additional information was requested.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The cartridge was returned inside the opened pouch that had been taped closed.Insufficient viscoelastic was observed dried in the cartridge.The cartridge nozzle was stressed on the anterior and cracked on the lower right side.The crack extended into the thinner tip material, creating an aneurysm that has split.The split extended along the lower right side throughout the tip.The tip has heavy stress.The cartridge has evidence of being placed into a handpiece.An iol product identification label had been affixed to the clear side of the pouch.This product was identified as the associated lens.Event date, patient initials, birthdate, doctor initial, and cartridge info was also handwritten on the pouch.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The customer indicated the use of a qualified diopter lens, handpiece and viscoelastic.The root cause for the reported event may be related to a failure to follow the dfu.An inadequate amount of viscoelastic was observed in the cartridge.The dfu instructs to fill the cartridge with viscoelastic before loading the lens.The damage along the right side of the nozzle started in the thick wall cone area.Unusually high internal forces would be needed to create damage in this area.The damage extended into the thinner material of the tip.The two distinct areas of damage would indicate a progressive change that occurred as the lens was advanced.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: 8440197
• MDR Text Key: 139570478
• Report Number: 1119421-2019-00345
• 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,Followup
• Report Date: 02/08/2021

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 Expiration Date: 10/31/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32674268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 04/02/2019; 01/31/2021
• Supplement Dates FDA Received: 04/04/2019; 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III HANDPIECE; SA60WF; VISCOAT
• Patient Age: 83 YR