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); Inadequacy of Device Shape and/or Size (1583); Failure to Deliver (2338)

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

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

The product was not returned for analysis.The cartridge 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 of a 25.5 diopter lens.The lens model is only qualified for cartridge with this lens model up to 25 diopters.The customer also indicated the use of a qualified cartridge, monarch iii handpiece and viscoelastic.The root cause is most likely related to a failure to follow the dfu.The account used an unqualified lens/cartridge combination.The lens model is only qualified with the cartridge up to 25 diopters.The use of non-qualified combinations may result in delivery issues and/or damage.(b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, the lens did not deliver smooth and the lens damaged.Additional information was received indicating the surgeon followed the lens model/diopter range chart and the lens was damaged due to the wrong sized cartridge being used with the lens.The procedure was completed using a different cartridge.An enlarged incision was required.

• 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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jason michaelides ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686438
• MDR Report Key: 9653543
• MDR Text Key: 177181707
• Report Number: 1119421-2020-00132
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH III C CARTRIDGES; MONARCH III IOL DELIVERY SYST; TFNT40, TFNT40 25.5 PANOPTIX TORIC; UNSPECIFIED DUOVISC VISCOELASTIC
• Patient Outcome(s): Required Intervention