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 Difficult to Remove (1528); Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.Additional information was requested.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that following the implant of an intraocular lens (iol) using a company cartridge a foreign material was found to be adhered on the back of the lens.The foreign material was unable to be removed during surgery.Additional information was requested.

Manufacturer Narrative

The complaint company iii (d) cartridge was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The indicated non-company lens is not qualified for use with the company iii (d) cartridge.It is unknown if a qualified handpiece and viscoelastic.The root cause for the reported complaint could not be determined.The used company iii (d) cartridge complaint sample was not returned.No determination can be made without physical evaluation of the complaint sample.A non-qualified iol was indicated.The use of non-qualified products may result in delivery issues and/or damage.The dfu states: the company iii iol delivery system is for implantation of company qualified foldable iols.No unqualified lenses should be used with the company iii iol delivery system.Although the root cause has not been determined, contributing factors could be: non-qualified iol: the use of a non-qualified product may result in delivery issues and/or damage.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).

• 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: 10950031
• MDR Text Key: 220224280
• Report Number: 1119421-2020-01829
• 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: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

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: 32767105
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZCB00 IOL