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 Fitting Problem (2183)

Patient Problem Corneal Edema (1791)

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints in the reported lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported a cartridge would not fit through the 2.4 millimeter incision during intraocular lens implant of the left eye.This caused stress on the wound and edema.Additional information received, the procedure was completed with a new cartridge noting a small epithelial defect that resolved without intervention.

Manufacturer Narrative

Corrected information provided in d.10.The product was not returned.Company cartridge product history records were reviewed, and the documentation indicated, the product met release criteria.The customer indicated, the use of an unspecified company lens model.Without the lens diopter, it cannot be determined, if this is a qualified combination.There were no other complaints reported in the lot number.The product investigation could not identify, a root cause for the reported complaint.The product was not returned to evaluate.File will be reopened when product is received.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: 11517431
• MDR Text Key: 241764115
• Report Number: 1119421-2021-00587
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 380659777639
• Combination Product (y/n): N
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

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: 15125236
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 04/28/2021
• Supplement Dates FDA Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ NATURAL SINGLEPIECE IOL; HEALON