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 Device Contamination with Chemical or Other Material (2944)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.The manufacturer internal reference number is: (b)(4).

Event Description

An ophthalmologist reported a response he received to a message he posted on behalf of another ophthalmic surgeon, that during three intraocular lens (iol) implantation procedures, there was debris on the posterior surface of all three iols.There were two cases of debris on the iols a few months ago and the surgeon was able remove the debris by irrigation and aspiration (i/a).The third iol with debris occurred this month.She was not able to remove the debris with i/a so had to exchange it.After saving the lens as a specimen/proof, noted that it was of course all clear of the debris once it was cut and out of the eye.Additional information was provided by the surgeon, who indicated that the issues seems to be with the cartridges."upon injection of lens, noted to have what appeared to be a scratch on the lens but seemed mobile.Was unable to clean off the lens so it was exchanged using a different injector" sutures were also required to close surgical wound.The patient's issue resolved and the surgeon's prognosis is good.There are three medical device reports associated with these three cases reported by an ophthalmologist in response to a message he received on behalf of another ophthalmic surgeon.This report is for the third of three cases.

• 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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 10280173
• MDR Text Key: 199727193
• Report Number: 1119421-2020-00986
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention