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 Activation, Positioning or Separation Problem (2906); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There were 3 other complaints in lot.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that during an intraocular lens (iol) implant procedure, the inner coating of the cartridge adhered to the back of the iol during lens insertion.The foreign material was completely removed from the lens and eye with the irrigation and aspiration system.The lens remains implanted with no harm to the patient.Additional information was requested.

Manufacturer Narrative

One used cartridge and thirteen unopened cartridges were returned for the reported lot number.The used cartridge was evaluated.Viscoelastic was observed in the cartridge.The cartridge has evidence of placement into a handpiece.Interior damage was observed on the left side of the tip.No foreign material was observed.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results for the presence of top coat.A disruption was observed in the interior coating on the left side of the tip.Review of the provided video shows a clear strip of material on the posterior surface of the optic.The material size and shape are consistent with the damaged interior coating of the returned used cartridge.The speed observed on the video may indicate the handpiece settings have been adjusted.Less than a one-second dwell was observed.One cartridge was pulled randomly from the thirteen unopened samples.The cartridge was microscopically evaluated with no abnormalities observed.The cartridge was functionally tested per the dfu.No lens or cartridge damage was observed after the lens delivery.No foreign material was observed.The cartridge was cleaned for further evaluation.Top coat stain testing was conducted with acceptable results.The indicated handpiece was used with a qualified iol.The indicated viscoelastic is not qualified for use with this combination.The root cause for the reported complaint could not be determined.Based on the review of the returned used cartridge and the provided video, the reported foreign material was most likely internal coating material from the cartridge tip.Review of the video also indicated the handpiece settings may have been adjusted.Less than a one-second pause was observed.Per the handpiece dfu: the qualified cartridge/iol combinations have been validated at an ambient temperature of 18 °c using the driving console setting (1.7 mm/sec, 3 seconds, and 3.0 mm/sec for initial velocity, pause and final velocity respectively).Using a higher velocity and shorter pause at lower temperatures, especially with high diopter lenses, could induce damage to iol and/or iol cartridge, affecting successful iol implantation.Although the root cause has not been determined, contributing factors could be: viscoelastic type: the use of a non-qualified viscoelastic may result in delivery issues and/or damage.And delivery speed: if the customer delivers the iol quicker than the dfu describes, this may result in delivery issues and/or damage.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: 11017235
• MDR Text Key: 222626944
• Report Number: 1119421-2020-01934
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

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: 32767105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DISCOVISC; INTREPID AUTOSERT; SN60WFA190,