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

Model Number III

Device Problems Failure to Advance (2524); Scratched Material (3020); Failure to Eject (4010)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/07/2022

Event Type  malfunction  

Event Description

A non healthcare professional reported during an intraocular lens implant procedure, the surgeon noticed some resistance as the plunger of the injector was advanced and was overriding the iol.The surgeon inspect the iol under the microscope, at this time it was noted that the optic of the iol had sustained a mark/scratch and therefore it was not implanted.Additional information has been requested.

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

Correction on h.8.: on initial mdr usage of device was captured as reuse.This should have been reuse of reusable device.A sample was not received, at the manufacturing site for evaluation.For the report of resistance, overrode lens, marked iol.Therefore, the condition of the product could not be verified.A photo of the iol packaging is attached to the parent file and has been reviewed by the investigation site.The photo is of the iol packaging only and is unrelated to this record.The cause of the reported event cannot be determined, with the information obtained.Therefore, specific action with regards to this complaint cannot be taken.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed, associated with the reported product and event.No additional action is required at this time.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: 14306545
• MDR Text Key: 290928570
• Report Number: 2523835-2022-00166
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380659777738
• UDI-Public: 00380659777738
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

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 Model Number: III
• Device Catalogue Number: 8065977773
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2022
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 06/29/2022
• Supplement Dates FDA Received: 07/22/2022
• 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 PANOPTIX UV TRIFOCAL IOL; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; NUVISC
• Patient Age: 59 YR
• Patient Sex: Female