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 Material Protrusion/Extrusion (2979); Material Split, Cut or Torn (4008)

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

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

A sample product was not returned for analysis.Product history records were reviewed and documentation indicates the product met release criteria.The iol product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.There are 6 other complaints in the lot.Additional information was requested.(b)(4).

Event Description

A technician reported that during an intraocular lens (iol) implant procedure, the tip of the cartridge split as the lens was being ejected out.The surgeon was able to pull the cartridge out of the eye with the lens still partially sticking out.The iol was removed without any damage.The lens was reloaded into another cartridge and implanted successfully.Additional information was requested.

Manufacturer Narrative

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: 8438216
• MDR Text Key: 139536687
• Report Number: 1119421-2019-00342
• Device Sequence Number: 0
• Product Code: MSS
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32674268
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 03/21/2019
• Supplement Dates FDA Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III HANDPIECE; SA60WF; VISCOAT
• Patient Age: 78 YR