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 Problems Failure of Implant (1924); Inflammation (1932)

Event Date 04/30/2019

Event Type  Injury  

Manufacturer Narrative

The product was returned for analysis.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.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported that on the first postoperative day, the haptic was noticed to have been broken and it was sitting in front of the iris.The iol was exchanged for the same lens model and power on the first postoperative day.Additional information was provided indicating that in the surgeon¿s opinion the cartridge damage to iol amputation of haptic is what caused the event.There was no significant inflammation.

Manufacturer Narrative

Evaluation summary: the cartridge complaint product was not returned for analysis.The cartridge 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 qualified 20.5 diopter lens was returned.The reported haptic damage was observed.The lens had other damage consistent with an explant.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: 8660374
• MDR Text Key: 146783421
• Report Number: 1119421-2019-00801
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DISCOVISC; IOL DELIVERY SYSTEM; SN60WF 20.5 D
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR