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 Defective Device (2588); Appropriate Term/Code Not Available (3191)

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

Event Date 06/16/2022

Event Type  malfunction  

Event Description

A physician reported that during the cataract surgery with intraocular lens implant procedure, cartridge found to have rough exterior edge during surgery.The physician noticed it when the tip of the cartridge ¿hung up¿ in the incision when implanting a monofocal with a injector.No patient harm was reported.Additional information has been requested.

Manufacturer Narrative

A loose, used company cartridge was returned.Viscoelastic is observed in and on the cartridge.No damage or roughness was observed.Dried ophthalmic viscosurgical devices (ovd) is observed on the tip.The used company cartridge was cleaned for further evaluation.The tip has a slight uneven appearance; however, this is a soft and flexible coating material on the beveled edge of the tip, a common byproduct of the interior coating process, and would be acceptable per our current release criteria.Product history records were reviewed and documentation indicated the product met release criteria.The root cause for the reported issue could not be determined.The returned company cartridge was microscopically evaluated.No roughness or damage was found.The tip has a slight uneven appearance; however, this is a soft and flexible coating material on the beveled edge of the tip, a common byproduct of the interior coating process, and would be acceptable per our current release criteria.There are no other complaints in this lot.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: 15042718
• MDR Text Key: 296095107
• Report Number: 1119421-2022-01560
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• 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: 15374788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON ASPHERIC UV ABSORBING IOL