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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endophthalmitis (1835); Blurred Vision (2137); Eye Pain (4467)

Event Date 12/05/2022

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 postoperative endophthalmitis during combined vitrectomy for retinal detachment and cataract surgery.The eye was already found cloudy by the exam of the slit lamp.The patient also complained of eye pain.Intraocular washing was performed.Backflush and other products of other companies are also suspected to be involved.Other equipment in the facility was also being investigated.Risk of disability was the surgeon's assessment.

Manufacturer Narrative

The sample has been received and in-house evaluation is in progress.The product was not returned.Product history records were reviewed, and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The used monarch iii (d) cartridge was not returned.There is no indication that the monarch iii (d) cartridge was related to the event.The investigation of causality is ongoing but the physician suspects operating room air conditioning.Therefore, he asked the professional vendor to investigate the air conditioner and replaced the filter of it.The investigation has been completed based on current information.Based on our current tracking, there are no adverse trends for this reported complaint.No further action warranted at this time.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: 16067297
• MDR Text Key: 306324206
• Report Number: 1119421-2022-02765
• Device Sequence Number: 1
• Product Code: MSS
• 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: 02/28/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: 15434423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 02/01/2023
• Supplement Dates FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BSS PLUS STERILE INTRAOCULAR IRRIGATING SOLUTION; CLAREON IOL; CONSTELLATION SURGICAL PROCEDURE PACK; FIBER OPTIC ILLUMINATOR; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Outcome(s): Required Intervention; Other; Disability
• Patient Age: 70 YR
• Patient Sex: Female