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 Device Contamination with Chemical or Other Material (2944)

Patient Problems Bacterial Infection (1735); Endophthalmitis (1835); Inflammation (1932)

Event Date 03/27/2023

Event Type  Injury  

Event Description

A physician reported that during the intraocular lens (iol) implant procedure, the physician complained that whitish fluffy material came out from cartridge.The physician washed it and administered anti bacterial drug thinking that there wont be any problem.However customer complained that the patient diagnosed with endophthalmitis and was suspecting the cartridge.The event was ongoing at the time of the report.The patient was hospitalized due to the event and the patient eye fluid was positive for pseudomonas aeruginosa.Additional information has been requested.Additional information received and stated that, uneventful left eye cataract surgery, noticed while fluffy material on iol implantation.Immediately removed the material with few bits entered in to the bay injected intracranial anti-bacterial, but still developed endophthalmitis with pseudomonal positive culture.Pain developed on 4th day after diminished vision, indicating vitritis first followed by unspecified reaction.The surgeon suspecting fluffy particle in cartridge.The lab data is positive for pseudomonas.The surgeon diagnosed endophthalmitis and toxic anterior segment syndrome.Intervention for the event was vitrectomy, anterior chamber wash, topical medication adjustment and iol explanation.Other treatment include: intravenous antibiotics, ceftriaxone, vancomycin, imipenem, olishia (unspecified).Intervention outcome for the event was unknown.It was stated that to some extent still patient is having continued fatigue.Event outcome continuing at the time of the report.There were no surgical complications.The event resulted clinically significant change.

Manufacturer Narrative

The product was not returned for analysis.Complaint and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is:(b)(4).

Manufacturer Narrative

The handpiece and viscoelastic used were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported foreign material.The company cartridge complaint product was not returned for evaluation.It cannot be determined if the cartridge was damaged.No determination can be made without physical evaluation of the complaint sample.The nature and origin of the material is unknown.The root cause for the reported endophthalmitis cannot be determined.Information was provided that the lens was removed and sent for testing.The results indicated the presence of pseudomonas aeruginosa.This would be unrelated to the company cartridge or the iol.Company cartridges and iols are terminally sterilized with 100% ethylene oxide sterilization.Company uses an overkill sterilization approach, which greatly exceeds the minimum requirements for sterility.Critical parameters for sterilization cycles are recorded and retained for every sterilization load to demonstrate that the acceptance criteria for the sterilization process are met.Pseudomonas aeruginosa is found in soil, water, skin flora, and most man-made environments throughout the world.Postoperative endophthalmitis caused by p.Aeruginosa has been reported in literature secondary to contamination of surgical solutions, instruments, or equipment.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: 16823797
• MDR Text Key: 314097389
• Report Number: 1119421-2023-00790
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 06/26/2023

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 Catalogue Number: 8065977763
• Device Lot Number: 15496171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/27/2023
• Supplement Dates Manufacturer Received: 05/31/2023
• Supplement Dates FDA Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF SINGLEPIECE IOL.
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 80 KG