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 Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  malfunction  

Event Description

A non-healthcare professional reported during the intraocular lens (iol) implant procedure the iol was scratched following the implantation.There was no patient harm.Additional information has been requested.There are three medical device reports associated with this file.This report is associated with the 1 of 3 files.

Manufacturer Narrative

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).

Manufacturer Narrative

Used company cartridge was returned.Inadequate viscoelastic was observed in the device.The tip had moderate stress.The cartridge had evidence of placement into a handpiece.The used company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.A qualified lens model/diopter was indicated with a non-qualified viscoelastic.The handpiece used was not provided.It is unknown if a qualified handpiece was used.No problem was found with the returned company cartridge.Top coat dye stain testing was conducted with acceptable results.The lens damage could not be verified.The lens was not returned for evaluation.The root cause for the reported ¿lens scratched¿ may be related to a failure to follow the ifu (instructions for use).Inadequate viscoelastic was observed in the returned used company cartridge.The ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.In addition, a non-qualified viscoelastic was indicated.It is unknown if a qualified handpiece was used.The ifu instructs: the company cartridges are qualified for use with compatible company handpieces for the surgical implantation of company qualified foldable iols.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18453867
• MDR Text Key: 332260052
• Report Number: 1119421-2024-00033
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2024

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: 8065977763
• Device Lot Number: 15682031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/31/2024; 02/28/2024
• Supplement Dates FDA Received: 02/28/2024; 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL; EYEFILL C 207005
• Patient Age: 62 YR
• Patient Sex: Female