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 Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during a cataract extraction with intraocular lens (iol) implant procedure, the tip of the plunger hit the bottom of the cartridge when the plunger was advanced for setting.As a result of the strong advance, the cartridge bottom became the shape like it was slightly hollow.As a result, the iol was implanted without any problem, but it seemed to be a defect in the cartridge shape.The surgery was performed and completed without product replacement.Additional information was provided that the shape like it was slightly hollow means the shape like spread out shape.It was implanted without problems, and there is no problem for the iol and the patient.

Manufacturer Narrative

Product evaluation: the cartridge was returned.Viscoelastic is only observed in one spot between the loading area and the nozzle entry area.There is no viscoelastic beyond this point.The cartridge has evidence it was placed into a handpiece; however, the cartridge does not appear to have delivered a lens.No cartridge damage is observed.Product history records were reviewed and documentation indicated the product met release criteria.Indicated associated product are qualified.No problem was found with the returned cartridge.The cartridge has evidence it was placed into a handpiece; however, the cartridge does not appear to have delivered a lens.No cartridge damage is observed.Viscoelastic was not observed in the nozzle or tip of the cartridge.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: 9928924
• MDR Text Key: 187482768
• Report Number: 1119421-2020-00622
• 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: 06/04/2020

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 Catalogue Number: 8065977763
• Device Lot Number: 32738610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2020
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 05/10/2020
• Supplement Dates FDA Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL DELIVERY SYST, 8065977773; PROVISC 0.85 OPHTH VISC SUB 1%, 0005690048; SN60WF.XXX, UNSPECIFIED POWER - ACRYSOF