MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON MONARCH IOL DELIVERY SYSTEM, CARTRIDGE; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number ASKU

Device Problems Device Damaged by Another Device (2915); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

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

An account manager reported that several lenses were dinged.Additional information has been requested and received stated that cartridge has two straight lenses that loaded improperly and the plunger slipped past the edge and end up hitting the central optic and the optic needing to be explanted.Additional information has been requested.

• Brand Name: MONARCH IOL DELIVERY SYSTEM, CARTRIDGE
• 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: 15861675
• MDR Text Key: 307723098
• Report Number: 1119421-2022-02472
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON ASPHERIC UV ABSORBING IOL; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE