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 Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: 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 surgeon reported that during a cataract procedure with intraocular lens implantation, foreign material was adhered to the back side of the iol.This was noticed after implantation.The foreign material was removed and the procedure was completed.The iol remains implanted.Patient harm was not reported.Additionally, it was reported that a non-qualified injector was used in combination with the iol, cartridge and viscoelastic.

Manufacturer Narrative

Evaluation summary: the complaint cartridge was not returned.Five cartridges were returned for the complaint lot.One of the five returned samples was opened for evaluation.The cartridge was microscopically examined with no damage observed.No particulate was observed inside the cartridge.The cartridge was functionally tested per the directions for use (dfu).No lens or cartridge damage was observed after the lens delivery.No foreign material was observed.The cartridge was cleaned for further evaluation.Top coat due stain testing was conducted with acceptable results.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.The root cause for the reported complaint could not be determined.No determination can be made without physical evaluation of the complaint sample.The manufacturer internal reference number is: (b)(4).

Event Description

The surgeon provided updated information after the initial report that the foreign material had disappeared from the iol.Patient outcome is good and there is no problem.

Manufacturer Narrative

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: 10861616
• MDR Text Key: 218180676
• Report Number: 1119421-2020-01733
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,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: 32761895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 01/10/2021; 02/04/2021
• Supplement Dates FDA Received: 02/03/2021; 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AE-9036SP.; PROVISC 0.85 OPHTH VISC.; SN(B)(6), ACRYSOF SP NATURAL.; VISCOAT 0.5ML VISCOELASTIC.