MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR; LENS, GUIDE, INTRAOCULAR

Model Number III

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/11/2021

Event Type  malfunction  

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).

Event Description

A physician reported that during a cataract extraction with implantation of an intraocular lens (iol), foreign material was noted on the back of the lens.The foreign material was removed by irrigation and aspiration (i/a) during the initial procedure.There was no patient harm.The surgeon considers that this was caused by multiple causes (coating materials of cartridge, oldness of injector, thickness of iol etc.) additional information was requested.

Manufacturer Narrative

A sample was not received, at the manufacturing site for evaluation.For the report of foreign material.Therefore, the condition of the product could not be verified.No lot number was identified, with this complaint.Therefore, a device history record review could not be conducted.A sample was not received, at the manufacturing site.And no lot information is available.Therefore, the root cause for the customer complaint issue cannot be determined.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12506046
• MDR Text Key: 272462773
• Report Number: 2523835-2021-00352
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380659777738
• UDI-Public: 00380659777738
• 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,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: III
• Device Catalogue Number: 8065977773
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ NATURAL SP IOL; HEALON; IOL GRASPING FORCEPS; MONARCH III IOL, CARTRIDGE D; ACRYSOF IQ NATURAL SP IOL; HEALON; IOL GRASPING FORCEPS; MONARCH III IOL, CARTRIDGE D