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 /Decontamination Problem (2895); Material Deformation (2976)

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

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.(b)(4).

Event Description

A physician reported that during a cataract extraction with intraocular lens (iol) implant procedure, the surgeon felt a strong resistance.An indentation around the optical part was confirmed, but the surgery was completed.The day after the surgery, the indentation disappeared, but a foreign material was confirmed behind the iol in the bag.The surgeon wants to check if the inside of the cartridge might have been scraped by the injector.There are two medical device reports associated with this event.This report is associated with the cartridge.

Manufacturer Narrative

The company iii (d) cartridge was not returned.Two photos were provided.Both are of the eye.The first photo has what appears to be a strip of material upper left quadrant.Unable to determine if on the posterior or anterior surface.The second photo is a magnified view.The material in this photo appears different that the first photo.Unable to determine if the material is in or on the eye.Company complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.The indicated lens and handpiece are qualified for use with the company iii (d) cartridge.A non-qualified viscoelastic was indicated.The root cause for the reported foreign material could not be determined.The company iii (d) cartridge was not returned.No determination can be made without physical evaluation of the complaint sample.A non-qualified viscoelastic was indicated.Strong resistance was reported.This could indicate the lens or plunger were not in proper positions for advancement or there was an inadequate amount of viscoelastic in the cartridge.Although the root cause has not been determined, contributing factors could be: viscoelastic type: the use of a non-qualified viscoelastic may result in delivery issues and/or damage.Viscoelastic amount: not using the appropriate amount of viscoelastic as described in the dfu may result in delivery issues and/or damage.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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

Event Description

Additional information has been received stating the foreign material remains in the same place as the day after the surgery, and is not in the pupil area.The patient is being followed up.

• 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: 10649893
• MDR Text Key: 211468377
• Report Number: 1119421-2020-01414
• 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: 10/30/2020

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?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 10/25/2020; 10/30/2020
• Supplement Dates FDA Received: 10/28/2020; 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL DELIVERY SYST, 8065977773, APD.; SN6AT8A210, SP ACRYSOF TORIC IQ, HWV.; UNSPECIFIED NON ALCON VISCOELASTIC.