MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Catalog Number 8065977763

Device Problem Detachment Of Device Component (1104)

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

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: two cartridges were returned.Inadequate viscoelastic was observed in both cartridges.The tips are heavily stressed and are cracked between the nozzle entry area and the tip area.The cracked damage extended into long aneurysm on each tip that has torn in the middle, stretching the tip material at the end.The lens was not returned.A photo was provided of the cartridge.The tip of the cartridge has a crack on the right side that extends back into the nozzle.The tip is split.Viscoelastic is not visible inside the cartridge.The lens associated with this complaint is a 21.5 diopter, which is qualified for the cartridge.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 iol 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.It is unknown if a qualified handpiece was used with the lens/cartridge combination.The reported tip damage was observed.The root cause appears to be a failure to follow the directions for use (dfu).An inadequate amount of viscoelastic was observed in both cartridges.The dfu instructs to fill the cartridge with viscoelastic before attempting to load the lens.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ophthalmic viscosurgical device (ovd), which may result in damage or delivery issues.The damage observed to the tip of the used cartridges typically occurs if the lens is not positioned correctly/folded correctly for advancement; if there is a lack of viscoelastic between the lens and the cartridge lumen; and/or if the handpiece plunger is not positioned correctly at the trailing optic edge.This can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge causing damage.It is unknown if a qualified viscoelastic was used.Due to differing material properties, the use of a non-qualified viscoelastic may result in delivery issues and/or damage.This product malfunction was originally reported under an alternative summary report (e2001023).The sample has been returned and investigation was updated, which prompts evaluation and conclusion coding to be updated.As the alternative summary report e2001023 has been revoked, the updated information (product investigation and coding) is being sent via this 3500a report.(b)(4).

Event Description

A surgeon reported that during a cataract extraction/intraocular lens (iol) implant procedure, the tip of the cartridge gave way and there was a crack line on the right side of the cartridge tip the moment the lens was injected into the patient¿s eye.Procedure was successfully completed and patient is doing well.

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7421527
• MDR Text Key: 105433511
• Report Number: 1119421-2018-00392
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 8065977763
• Device Lot Number: ASKU
• Other Device ID Number: 00380659777639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other