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 Problem Break (1069)

Patient Problem Edema (1820)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

The cartridge product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.The iol product history records were reviewed and documentation indicates the product met release criteria.The product investigation could not identify a root cause.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that during an intraocular lens (iol) implant procedure, the injector cut off the iol haptic.The iol was removed and replaced with a new lens.The procedure was completed.The event is improving.The patient experienced "diffuse edema" after surgery due to the handling of the broken lens in order to change it to a new lens.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: the cartridge was not returned.The cartridge product history records were reviewed and documentation indicated the product met release criteria.The customer indicated the use of a qualified model and diopter lens.The indicated viscoelastic is not qualified for use with the cartridge/iol combination used.The indicated handpiece model was not provided.It cannot be determined if a qualified handpiece was used.The reported complaint indicated the injector.It i unclear if this was referring to the handpiece or the cartridge.The root cause for the reported haptic damage may be related to a failure to follow the directions for use (dfu).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: 8458246
• MDR Text Key: 140290396
• Report Number: 1119421-2019-00353
• 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,other
• Type of Report: Initial,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32622654
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CANETA ELLIPS; INJECTOR ASICO ROYALE III; SN60WF 26.5 DIOPTER; VISCOELASTIC - OCUCOAT