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 Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 01/09/2020

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.Additional information was requested.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, the cartridge was noted to be damaged.It was also reported the iol would not go into the cartridge properly due to a folding issue.The lens became stuck during lens insertion.Additional information has been requested.

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.The monarch complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The customer indicated the use of a qualified 24.5 diopter lens with a qualified handpiece.Two viscoelastics were indicated, only one is qualified for this lens/cartridge combination.The product investigation could not identify a root cause for the reported complaint.Not enough information was provided from the account for further investigation.Additional information provided in h.6.And h.10.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: 9684917
• MDR Text Key: 182721019
• Report Number: 1119421-2020-00204
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2020
• 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: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL DELIVERY SYST.; SN6AT2.245, SP ACRYSOF TORIC IQ.; UNSPECIFIED PROVISC OVD, 000451, BEL.; UNSPECIFIED VISCOAT OVD, 000452, BEL.