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 Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

The used monarch iii (d) cartridge was returned.Viscoelastic was observed in the cartridge.The cartridge had evidence of placement into a handpiece.No cartridge damage was observed.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.A photo was provided of the distal portion of one haptic.The haptic tip was torn.The torn material from the haptic tip may have been interpreted as foreign material.Acrysof natural material has a white appearance when damaged.The acrysof lens is not melted.Product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.A qualified lens model was indicated.The handpiece and viscoelastic information was not provided.It is unknown if qualified products were used.No problem was found with the returned used cartridge.Top coat dye stain testing was conducted with acceptable results.It is unknown if a qualified handpiece and viscoelastic were used.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.Follow the section regarding directions for use for information on the maximum allowed time for the iol to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in iol damage.Ifu note: during lens loading and insertion, do not allow the clareon iol to remain in a folded condition within the selected iol delivery system for more than 3 minutes prior to completing insertion into the capsular bag.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that once the intraocular lens (iol) was implanted, a foreign material was observed on the trailing haptic.The iol was removed during surgery because the foreign material could not be removed by irrigation & aspiration.When iol was removed, the trailing haptic was checked, and it (trailing haptic) was clearly attached.The doctor said that the lens seemed to have melted.The surgery was completed after replacing the iol with another one in an initial procedure.Additional information was requested, but no further information is available.

• 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: 16689626
• MDR Text Key: 312865145
• Report Number: 1119421-2023-00605
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• 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: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON TORIC IOL