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

Catalog Number	8065977762
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11915884
• Report Number: 1119421-2021-01142
• Device Sequence Number: 13573094
• Product Code: MSS
• UDI-Device Identifier: 00380659777622
• UDI-Public: 00380659777622
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K112977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2025
• Device Catalogue Number: 8065977762
• Device Lot Number: 15080954
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACRYSOF IQ NATURAL SINGLEPIECE IOL.; ROYALE INJECTOR.; VISCOELASTIC.