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 Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/06/2019

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 three 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, a small amount of debris was observed in the patient's eye after the lens was implanted, which appeared to be adherent to the lens.The debris was removed by the irrigation/aspiration handpiece during the initial procedure.Additional information has been requested.

Manufacturer Narrative

Product evaluation: the cartridge was not returned for evaluation.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.The associated iol is not qualified for use with the cartridge model.The product investigation could not identify a root cause.The cartridge was not returned for evaluation.A non-qualified cartridge/iol combination was used.Use of non-qualified cartridge/iol combinations may result in delivery issues and/or damage.It is unknown if a qualified handpiece and viscoelastic were used.Additional information provided in h.3., 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: 9397897
• MDR Text Key: 175453123
• Report Number: 1119421-2019-02033
• 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,u
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

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 Expiration Date: 12/31/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32690781
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SA60AT.210FX.; UNK I/A HANDPIECE.