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)

Patient Problem Eye Injury (1845)

Event Date 03/27/2023

Event Type  Injury  

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 intraocular lens (iol) implant procedure, the implantation of an iol through a 2.2 mm corneal incision using the original company injector and viscoelastic was done.The plunger moved harder than usual, and one haptic element was almost detached from the optical part.During the operation, due to the lack of central position of the iol, a decision was made to explant the iol through a 2.5 mm corneal incision with forceps for iol and suturing the cornea with a 10/0 thread.The replacement iol of the same model and power was implanted.During the removal of the iol and passing it through the valve incision of the cornea, the haptic completely detached.There was no patient harm.Additional information has been requested and received stated that posterior haptic was detached and the current condition of a patient is satisfactory.

Manufacturer Narrative

Corrected information provided in h.8.On initial mdr the h8 ¿initial use¿ was submitted in error, it should have been ¿reuse of reusable device¿ in the original mdr.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Correction: on initial mdr the product code of 2915 was reported.There should have been 2588 also on the original mdr.A sample was not received at the manufacturing site for evaluation for the report of the plunger moved harder than usual and haptic was detached during surgery; therefore, the condition of the product could not be verified.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.A sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, 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: 16814535
• MDR Text Key: 313996675
• Report Number: 2523835-2023-00186
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380659777738
• UDI-Public: 00380659777738
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2021
• Device Model Number: III
• Device Catalogue Number: 8065977773
• Device Lot Number: 864907¿
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 05/11/2023; 06/27/2023
• Supplement Dates FDA Received: 06/08/2023; 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ NATURAL SINGLEPIECE IOL; MONARCH III CARTRIDGE D; OCU-COAT VISCOELASTIC; UNSPECIFIED FORECEPS
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male