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 Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been three other complaints reported in the lot number.(b)(4).

Event Description

A customer reported an intraocular lens (iol) that was damaged by the cartridge during implantation.The surgery was performed and completed without product replacement.Additional information is requested.

Manufacturer Narrative

The used cartridge was returned loose.The cartridge is a cavity 2.Inadequate viscoelastic is observed in the cartridge.The cartridge has evidence of placement into a handpiece.There is a disruption in the coating observed on the left side of the tip.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results for presence of top coat.An internal disruption was observed on the left side.A non-qualified viscoelastic was indicated.The root cause for the reported lens damage not be determined.The lens remains implanted.The returned used cartridge was damaged.Material from the damaged cartridge may have been interrupted as the reported lens damage.A non-qualified viscoelastic was indicated.It is unknown if the iol was in the qualified diopter range.The use of non-qualified combinations may result in delivery issues and/or damage.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: 11017315
• MDR Text Key: 222633160
• Report Number: 1119421-2020-01940
• 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

• Date FDA Received: 12/16/2020
• 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?: Yes
• Date Returned to Manufacturer: 12/07/2020
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTREPID AUTOSERT IOL INJECTOR, 8065751755, ITC; OPEGAN-HI; SV25T0.XXX, UNSPECIFIED POWER - SP ACRY IQ RESTOR