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

Catalog Number 8065977762

Device Problems Break (1069); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

A sample device was not 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 reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, the haptic broke at the moment of injection.The nurse reported the cartridge may have been defective.An incision had been made and there was patient contact, but no patient harm.There was a 20 minute delay in the procedure.A sample is available.Additional information has been requested.

Manufacturer Narrative

The customer indicated the use of a non-qualified lens and cartridge combination.The root cause is most likely a failure to follow the dfu.The use of non-qualified combinations may result in delivery issues and/or damage.Additional information provided.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, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8210589
• MDR Text Key: 132065420
• Report Number: 1119421-2019-00010
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 8065977762
• Device Lot Number: 32619152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION; MA60AC 23.5D IOL