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 Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A customer reported during the implant of an intraocular lens (iol), the head of the cartridge burst.There was no reported patient impact.Additional information was requested.

Manufacturer Narrative

Additional information provided.The product was not returned.All product and batch history records are quality reviewed prior to product release.The customer indicated the use of an unspecified iol.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.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: 9234028
• MDR Text Key: 170120805
• Report Number: 1119421-2019-01785
• 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: 12/29/2019

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: 09/30/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32661263
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 12/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED IOL