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 Failure of Implant (1924)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product in transit to the investigator.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.(b)(4).

Event Description

A nurse reported that during a cataract surgery with an intraocular lens (iol) implantation, the cartridge broke suddenly without reason.The cartridge came in contact with the patient.There was no patient harm and the operation was completed by using another new cartridge.

Manufacturer Narrative

Evaluation summary: a used cartridge was returned.An inadequate amount of viscoelastic is observed in the cartridge.There is evidence the cartridge was placed into a handpiece.The tip is split on the bottom right.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The root cause for the damage may be related to a failure to follow the directions for use (dfu).There did not appear to be adequate viscoelastic 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 viscoelastic, which may result in damage or delivery issues.Top coat dye was conducted with acceptable results.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: 9211422
• MDR Text Key: 168468294
• Report Number: 1119421-2019-01731
• 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: 12/20/2019

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 Expiration Date: 12/31/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32685185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1