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 Difficult to Remove (1528); Scratched Material (3020)

Patient Problem Insufficient Information (4580)

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, the iol was loaded into the cartridge, the introducer passed over the lens and was unable to be inserted.It was difficult to remove the lens from cartridge and tying forceps were used to remove.The iol was reloaded and partially inserted into the patient's eye.The iol was removed again and a scratch was noted on the lens.The cartridge was reported to be faulty and the procedure was completed with a backup lens.

Manufacturer Narrative

There have been no other complaints reported in the lot number.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: 10521327
• MDR Text Key: 207698276
• Report Number: 1119421-2020-01247
• 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
• Report Date: 10/06/2020

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 Catalogue Number: 8065977763
• Device Lot Number: 15005960
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: DUOVISC VIS SYSTEM; MONARCH III IOL DELIVERY SYST; NORDON TYING FORCEPS; SN60WF.215, ACRYSOF SP NATURAL IQ
• Patient Age: 82 YR