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 Problems Break (1069); Split (2537)

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

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

The product 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 no other complaints reported in the lot number.Attempts have been made to obtain additional information.(b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, a cartridge split/broke.There was no patient injury, illness or impact, and no unplanned treatment or surgical intervention required.Additional information was requested.

Manufacturer Narrative

Product evaluation: the cartridge was returned.An inadequate amount of viscoelastic is dried in the cartridge.The tip has heavy stress and is cracked beginning behind the nozzle.This damage extends into a splitting of the anterior tip.The iol is damaged, partially extending out of the split tip anterior.Both haptics are folded in onto the optic.The optic edge is torn.The cartridge product history records were reviewed documentation indicated the product met release criteria.The customer indicated the use of a qualified lens.Iol product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a qualified handpiece and viscoelastic.The reported tip damage was observed.The root cause may be related to a failure to follow the directions for use (dfu).An inadequate amount of viscoelastic was observed.The dfu instructs to fill the cartridge with viscoelastic before loading 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.This type of damage is typically progressive and worsens as the lens is advanced.The damage 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.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 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, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7183928
• MDR Text Key: 97084120
• Report Number: 1119421-2018-00040
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

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: 08/31/2022
• Device Catalogue Number: 8065977763
• Device Lot Number: 32572285
• Other Device ID Number: 380659777639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2017
• 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