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 Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/11/2019

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported that during an intraocular lens (iol) implant surgery, the cartridge was faulty which resulted the removal of the implanted lens during the initial procedure.The surgeon had to widen the incision to remove the lens and replaced it with a new iol.The patient has experienced induced astigmatism.Additional information has been requested.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been received stating the procedure was completed on the same day.

Manufacturer Narrative

Additional information provided in h.3., and h.10.The product was not returned.All product and batch history records are quality reviewed prior to product release.The customer indicated the use of a non-qualified lens for this cartridge.The root cause is most likely a failure to follow the dfu.The account used a non-qualified lens/company product combination.The use of non-qualified combinations 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: 9513052
• MDR Text Key: 172769410
• Report Number: 1119421-2019-02191
• 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,Followup
• Report Date: 02/03/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32654009
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 12/30/2019; 01/31/2020
• Supplement Dates FDA Received: 12/31/2019; 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SA60AT IOL.
• Patient Outcome(s): Other