MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Catalog Number 8065977762

Device Problems Stretched (1601); Difficult to Advance (2920)

Patient Problem Corneal Edema (1791)

Event Date 05/12/2021

Event Type  malfunction  

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 nurse reported a broken intraocular lens (iol) while moving the injector.Additional information was provided indicating that according to the surgeon, the event was due to the cartridge.The lens did not slide well through the cartridge even with the viscoelastic inside.The cartridge nozzle was already in the incision and the intraocular lens was being inserted.When the surgery was finished they noticed small stretch marks inside of it.Corneal edema was observed.The corneal edema is attributed to the contact of the iol with the patient or what was the reason: it is attributed to the manipulation of the removal of the lens with the fractured proximal haptic (it had already entered the capsular bag), and the entry of a new lens.The intervention was described as immediate iol removal, replacement and eye medication treatment.

Manufacturer Narrative

Evaluation summary: the product was not returned.Two photos were provided.One photo shows a top view of the cartridge.There does not appear to be adequate viscoelastic in the cartridge.The cartridge has evidence of placement into a handpiece.No tip damage can be discerned in the photo.A photo was provided of the lens in the lens case.The qualified lens was posterior side up, oriented incorrectly.One haptic was observed to be broken-gusset area.A competitor's handpiece was indicated.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 C
• 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: 11915884
• MDR Text Key: 253998901
• Report Number: 1119421-2021-01142
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777622
• UDI-Public: 00380659777622
• Combination Product (y/n): N
• PMA/PMN Number: K112977
• 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: 08/17/2021

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 Catalogue Number: 8065977762
• Device Lot Number: 15080954
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/01/2021
• Supplement Dates Manufacturer Received: 08/06/2021
• Supplement Dates FDA Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ NATURAL SINGLEPIECE IOL.; ROYALE INJECTOR.; VISCOELASTIC.