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 Noise, Audible (3273); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.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.Root cause has not been identified.Additional information has been requested.(b)(4).

Event Description

A surgical technician reported that when an intraocular lens (iol) was being loaded, the cartridge split and made a sound.Another cartridge was used to complete the procedure with no patient harm.Additional information has been requested.

Manufacturer Narrative

Product evaluation: the used cartridge was returned taped to a business card.Inadequate viscoelastic is observed in the cartridge.The cartridge does show evidence it was placed into a handpiece.The nozzle is cracked.There is a large aneurysm that splits as it enters the tip on the top.The tip has heavy stress.Cartridge 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 an unspecified iol, with a cartridge, handpiece, and viscoelastic.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.The reported cartridge damage was observed.The root cause for the observed damage may be related to a failure to follow the dfu.Inadequate viscoelastic was observed in the cartridge.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 ovd, which may result in damage or delivery issues.The nozzle was cracked and had an aneurysm, which split as it entered the thinner tip area.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.Unusually high internal forces would be needed to create damage in this area.The distinct area of damage would indicate a progressive change that occurred as the lens was advanced.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 to 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, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8512438
• MDR Text Key: 142194367
• Report Number: 1119421-2019-00476
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

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 Catalogue Number: 8065977763
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/13/2019
• Supplement Dates Manufacturer Received: 07/12/2019
• Supplement Dates FDA Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III HANDPIECE; PROVISC OVD; UNSPECIFIED ALCON IOL