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 Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during a cataract extraction with intraocular lens (iol) implant procedure, lens loading was performed as usual, placed in an automatic inserter and advanced.Progress is observed without complications.At the moment the iol is implanted in the patient, it is observed that there is a line in the lens optic.The iol was removed and a new one was implanted.Cause of event is an imperfect cartridge.Additional information was requested.

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6., and h.10.Product evaluation: the reported cartridge was returned in an opened pouch.The used cartridge was evaluated.Viscoelastic is observed in the cartridge.The cartridge has evidence it was placed into a handpiece.The tip of the cartridge has heavy stress and an aneurysm on the bottom right.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and documentation indicated the product met release criteria.The associated lens model was not provided.It is unknown if a qualified model/diopter was used.The indicated handpiece is qualified for use with this cartridge for specific lens model/diopter combinations.The root cause for the reported lens damage could not be determined.The cartridge was damaged.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: 9856887
• MDR Text Key: 186207621
• Report Number: 1119421-2020-00472
• 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: 06/04/2020

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 Expiration Date: 05/31/2024
• Device Catalogue Number: 8065977763
• Device Lot Number: 32722659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Initial Date Manufacturer Received: 02/22/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 05/10/2020
• Supplement Dates FDA Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTREPID AUTOSERT IOL INJECTOR.; UNSPECIFIED IOL, HWV.