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

Catalog Number 8065977758

Device Problem Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2024

Event Type  malfunction  

Event Description

A non-health care professional reported cartridge scratched the lens.

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

The product was not returned.Photos were provided.A photo was provided which showed the carton with the label end cap visible.A lens case base was also pictured on top of a small piece of paper.A multi-piece lens was visible in the lens case base.There appeared to be solution and possibly blood or betadine on the lens.The reported scratch could not be observed due to the magnification of the photo.A second photo was also provided of two company cartridges (b) and (c) on top of the corresponding company pouches.The company (b) cartridge is for this file.The company (b) cartridge on top of the pouch is bottom up.The cartridge appears unused or inadequate viscoelastic was placed in the cartridge.Product history records were reviewed and documentation indicated the product met release criteria.The handpiece and viscoelastic used were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Photos were provided.The quality of the photo did not allow for visualization for the reported scratch.The pictured cartridge appeared unused or inadequate viscoelastic was placed in the cartridge.It is unknown if a qualified handpiece and viscoelastic were used.The ifu instructs: the company iol delivery system is for implantation of qualified company foldable iols.No unqualified lenses should be used with the company iol delivery system.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 ifu(instructions for use) 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.File will be reopened if the sample is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B
• 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: 19058906
• MDR Text Key: 339781751
• Report Number: 1119421-2024-00652
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777585
• UDI-Public: 00380659777585
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K001157
• 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
• Report Date: 05/31/2024

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: 8065977758
• Device Lot Number: 15681851
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CRYSTAL FOLDABLE MULTIPIECE IOL.
• Patient Age: 65 YR
• Patient Sex: Female