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 Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2019

Event Type  malfunction  

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 two other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, the cartridge had a greater than normal stress fracture that occurred during lens injection into the eye.There was no patient harm or case delay.Additional information has been requested and received.

Manufacturer Narrative

Product evaluation: the cartridge was returned in the opened pouch, along with the lens case of the associated lens, and a cartridge in an unopened pouch.Only a small amount of viscoelastic was observed in the cartridge.Light stress lines are observed beginning prior to the parting line/fill to line on the anterior and posterior cartridge surfaces.Heavier stress lines are observed along the right side of the tip.The cartridge shows evidence of being placed into a handpiece.Stress lines were observed.The stress marks are an expected occurrence with a lens delivery and do not denote a product deficiency.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: 8594572
• MDR Text Key: 144691606
• Report Number: 1119421-2019-00637
• 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,other
• Type of Report: Initial,Followup
• Report Date: 08/09/2019

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: 10/31/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32676377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 05/09/2019
• Supplement Dates Manufacturer Received: 07/16/2019
• Supplement Dates FDA Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MC PHERSON FORCEPS; MONARCH III IOL DELIVERY SYSTEM; SN6AT3 20.5; VISCOAT
• Patient Age: 66 YR