MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Catalog Number 8065977762

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2018

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 similar complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, when injecting the lens in the cartridge the cartridge broke the tip.In a second attempt with another cartridge, the tip broke and broke the lens in the middle.Additional information has been requested.There are two reports associated with this event.This report is for the second of two cartridges.

Manufacturer Narrative

Product evaluation: three cartridges were returned in a small plastic bag with a sticker identifying them for this complaint.It cannot be determined which cartridge was used for this file.All three will be evaluated.Cartridge #1: viscoelastic is observed in and on the outside of the cartridge.The cartridge has evidence it was placed into a handpiece.The tip is not broken.Heavy stress is observed, with areas on each side of the tip midway which are pressed out.There is a small aneurysm on the bottom left of the tip.Cartridge #2: viscoelastic is observed in and on the outside of the cartridge.The cartridge has evidence it was placed into a handpiece.The tip has a large aneurysm at the parting line which has torn and split through the end of the tip.There is another aneurysm on the bottom left of the tip.Cartridge #3: viscoelastic is observed in and on the outside of the cartridge.The cartridge has evidence it was placed into a handpiece.The tip is not broken.Heavy stress is observed.The bottom of the tip has two aneurysms on the right and left side.The tip has a large dented in area which has cause cracks in the bottom of the nozzle.This damage may have been caused during return due to the product being shipped loose.It is unknown if qualified products were used.The root cause for the observed damage cannot be determined.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C
• 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: 8178100
• MDR Text Key: 130983371
• Report Number: 1119421-2018-01766
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• PMA/PMN Number: K112977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 8065977762
• Device Lot Number: 32606789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED IOL
• Patient Age: 87 YR