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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that following a cataract extraction with intraocular lens (iol) implant procedure, some piece of the metal had been left in the eye.Additional information has been requested and received stated that on (b)(6) 2021,removal of foreign material was performed during the surgery of another eye.Two pieces of foreign material was removed with healon and forceps for iol.Visual acuity was recovered with no problem.

Manufacturer Narrative

A sheet of gauze was returned.An orange arrow was taped to the sheet of gauze.Microscopic examination shows a very small dark/shiny particle taped to the gauze in front of the arrow indicator.The particle lab analyzed the sample.The gauze was visually and microscopically examined, and the reported foreign material was observed.Microscopic examination showed a dark, reflective particle approximately 345 m in length.The dark, reflective particle was isolated and analyzed using the scanning electron microscope (sem) equipped with an edax energy dispersive x-ray spectrometer (eds).Eds analysis of the reflective particle identified carbon (c), aluminum (al), titanium (ti), and vanadium (v).The presence of these elements along with the visual characteristics suggests the reflective particle is titanium alloy.A non-company handpiece and lens were indicated.The non-company handpiece model indicated is made of titanium per the product information.The presence of these elements along with the visual characteristics suggests the reflective particle is titanium alloy.Titanium products are not used in the manufacture of monarch cartridges.The non-company handpiece model indicated is made of dark gray titanium per the product information.The handpiece may be a possible source for the particle.The origin of the titanium particle cannot be determined.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: 13119351
• MDR Text Key: 282976837
• Report Number: 1119421-2021-02514
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• 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: 03/17/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 02/21/2022
• Supplement Dates FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AE-9063CSP; AMO; HEALON
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female