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 Break (1069)

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

Event Date 07/26/2018

Event Type  malfunction  

Manufacturer Narrative

The cartridge was returned.Inadequate viscoelastic was observed inside the cartridge.The tip has stress in varying degrees from light to heavy.Stress lines are present beginning in the nozzle wall prior to the parting line.The posterior tip exit has a small aneurysm observed.The cartridge shows evidence of being placed into a handpiece.The cartridge was not split.The product history records were reviewed and documentation indicated the product met release criteria.The customer indicated the use of a qualified lens and handpiece.Two viscoelastics were indicated and both are qualified for the lens/cartridge combination used.The file indicated one of the qualified viscoelastics was placed in the end of the cartridge prior to loading the lens.It is unknown if the loading area or the tip end was the point of reference.The dfu instructs the user to fill the cartridge with viscoelastic.A diagram is also shown in the dfu of the viscoelastic cannula entering at the loading area.The root cause may be related to a failure to follow the dfu.An inadequate amount of viscoelastic was observed.The stress and small aneurysm observed are an expected occurrence with a lens delivery and do not denote a product deficiency.However, it can be more pronounced if there is an inadequate amount of viscoelastic between the lens and the cartridge lumen or if the lens is not positioned correctly.In addition, if the handpiece plunger is not positioned at the trailing optic edge it can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge, which could cause damage to the tip or the lens.The stress begins at the nozzle wall prior to the parting line.This type of damage is typically progressive and worsens as the lens is advanced.The stress on the top of the nozzle started in the thick wall cone area of the nozzle.Unusually high internal forces would be needed to create damage in this area.This type of damage typically occurs if the lens is not positioned correctly for advancement; if there is a lack of viscoelastic between the lens and the cartridge lumen; if the lens is advanced too rapidly or if the handpiece plunger is not positioned correctly at the trailing optic edge.There are no other complaints in the lot.Additional information was requested.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported that during an intraocular lens (iol) implant procedure the tip of the cartridge split while lens was being implanted into the patient's eye.The lens was able to be placed and stabilized with no harm to the patient.The viscoelastic was removed from refrigerator 45 minutes prior to surgery and there were no issues when the lens was advancing in the injector.

• 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: 7806328
• MDR Text Key: 118156685
• Report Number: 1119421-2018-01184
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32615870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2018
• 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
• Patient Age: 78 YR