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 Break (1069); Crack (1135)

Patient Problem Failure of Implant (1924)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Product evaluation: complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause: root cause has not been identified (b)(4).

Event Description

A doctor reported an intraocular lens (iol) cartridge broke during a cataract with iol implant procedure.The crack occurred at the nozzle top of the cartridge when implanting the iol.There was no patient impact reported.

Manufacturer Narrative

The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified lens/cartridge combination was indicated.A non-qualified handpiece was indicated.The viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The root cause is most likely related a failure to follow the dfu.The account used a cartridge/handpiece combination which was not qualified for use.The use of non-qualified combinations may result in delivery issues and/or damage.Procedures and processes exist within the manufacturing environment that focus on protection of the cartridge tip.There are two other complaints in this lot.Investigation has been completed based on current information.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in d.9, h.2, h.3, h.6.And h.10.Product evaluation: the cartridge was returned in a small plastic bag.Viscoelastic was observed dried throughout the cartridge.Stress line was observed in the thick nozzle cone wall along the anterior and posterior.The stress extended into the tip.The cartridge tip has heavy stress lines and a posterior aneurysm that has torn at the tip exit.This damage was most likely interpreted as the reported complaint of "broken".The cartridge has evidence of being placed into a handpiece.A photo in the file matched the condition of the returned sample.All product and batch history records are quality reviewed prior to product release.A qualified lens and unknown handpiece were used with the cartridge.A non-qualified viscoelastic was indicated.Root cause: the cartridge had heavy stress beginning in the nozzle that extended into the tip.The tip had an aneurysm that has split at the tip exit on the posterior.This was most likely interpreted as the reported complaint.The root cause may be related to a failure to follow the dfu.The viscoelastic indicated was not qualified for the lens/monarch combination used.Due to differing material properties, the use of a non-qualified viscoelastic 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: 11141183
• MDR Text Key: 227059213
• Report Number: 1119421-2021-00054
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• 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: 15052955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HAMERON INJ; TFNT00 22.5 AS IQ PANOPTIX