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 Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: 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 four other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported during the implant of an intraocular lens (iol), a piece of the cartridge nozzle tip broke off and went into the eye.The surgeon removed the piece and there was no reported patient impact.Additional information was requested.

Manufacturer Narrative

Four company cartons were returned for the reported company iii (d) cartridge lot# 15075819 (two were unopened).There were 33 unopened company ii (d) cartridges returned.The used complaint company (iii) d cartridge was not returned.One sample was randomly pulled from each returned carton for lot # 15075819.The samples were numbered 1-4 for evaluation purposes.The returned unopened company iii (d) cartridges were microscopically examined and no damage or abnormalities were observed.The four company iii (d) cartridges were functionally tested per the dfu.No lens or cartridge damage was observed after the lens delivery.No foreign material was observed.The four cartridge were 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.Associated products were not provided.It is unknown if a qualified lens model/diopter, handpiece and viscoelastic were used.The root cause for the reported cartridge damage could not be determined.The used complaint company iii (d) cartridge was not returned for evaluation.Functional and dye stain testing was conducted with four of the returned unopened company iii (d) cartridges for lot 15075819.No lens or cartridge damage was observed after the delivery.No foreign material was observed.Top coat dye stain testing was conducted with acceptable results.It is unknown if a qualified lens model/diopter, handpiece and viscoelastic were used.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: 10968212
• MDR Text Key: 220902264
• Report Number: 1119421-2020-01862
• 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: other
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• 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: 15075819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Date Manufacturer Received: 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1