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

Model Number III

Device Problems Defective Device (2588); Device Damaged by Another Device (2915); Failure to Eject (4010)

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

Event Date 03/03/2023

Event Type  malfunction  

Event Description

A pharmacist reported that during loading the iol in the cartridge, the injector shaft passed over the implant leaving a mark in the center of the iol.The injector shaft appears to be out of alignment, with the tip pointing to the right.The lens was not injected into patients eye and the surgery was completed with back up implant with no problem to patient.Additional information was requested and associated product detail was received.

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

One opened handpiece injector was received for the report of injector shaft passed over the implant leaving a mark in the iol and injector shaft appears to be out of alignment.A visual inspection of the handpiece injector was performed and was found to be conforming.A dimensional plunger position height check was performed and was found to be conforming.Finally, a functional thread to barrel engagement check was performed and was found to be conforming.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.Two photos attached to the parent complaint were reviewed by the investigation site.Photo 1 shows a partial view (plunger and barrel distal end) of an injector due to its blue color.Photo 2 show an injector etched with same product and lot number as reported.The reported event cannot be confirmed on the photos attached.The returned sample was found to be conforming for all visual inspections, dimensional inspections and functional tests, associated with the reported event, therefore injector shaft passed over the implant leaving a mark in the iol and injector shaft appears to be out of alignment as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.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: 16672104
• MDR Text Key: 312594865
• Report Number: 2523835-2023-00134
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380659777738
• UDI-Public: 00380659777738
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

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: 13E155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 06/04/2023
• Supplement Dates FDA Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ PANOPTIX TRIFOCAL IOL; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; REPLACEMENT LENS- BACK UP IOL UNSPECIFIED; Z-HYALIN (OVD)