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 Burst Container or Vessel (1074); Difficult to Advance (2920)

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

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a qualified lens model and a viscoelastic.The associated handpiece product was not provided.Without the lens model's diopter and the handpiece information it cannot be determined if this is an approved product combination.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported during the implant of an intraocular lens (iol) the cartridge burst.The surgeon reports the cartridge material was 'somewhat milky than usual'.The lens was also difficult to advance.Additional information was requested.

Manufacturer Narrative

The monarch iii (d) cartridge complaint sample was not returned.Thirty-eight unopened company iii (d) cartridges lot#32721929 were returned identified for this complaint.Four samples were pulled randomly, one from each returned carton, for evaluation.The cartridges were visually examined with no abnormalities observed.Functional and dye stain testing was conducted with acceptable results.No lens or cartridge damage was observed.Cartridge product history records were reviewed and the documentation indicated the product met release criteria.The associated iol diopter was not provided.It cannot be determined if this was an approved combination without the diopter information.The indicated viscoelastic is approved for this cartridge with the iol in the qualified diopter range.The handpiece used was not provided.It is unknown if a qualified handpiece was used.The root cause for the reported company cartridge damage could not be determined.The complaint company iii (d) cartridge sample was not returned.It is unknown if a qualified associated product combination was used because the handpiece and the lens diopter information was not provided.Although the root cause could not be determined, contributing factors could be: a.Viscoelastic amount: not using the appropriate amount of viscoelastic as described in the dfu may result in delivery issues and/or damage.B.Iol: the use of non-qualified lens model/diopter may result in delivery issues and/or damage.C.Delivery speed: if the customer delivers the iol quicker than the dfu describes, this may result in delivery issues and/or damage.D.Handpiece: the use of non-qualified handpiece 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: 9904449
• MDR Text Key: 187482870
• Report Number: 1119421-2020-00571
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

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: 05/31/2024
• Device Catalogue Number: 8065977763
• Device Lot Number: 32721929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2020
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 03/31/2020
• Supplement Dates Manufacturer Received: 05/18/2020
• Supplement Dates FDA Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROVISC