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 Damaged by Another Device (2915)

Patient Problem No Patient Involvement (2645)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was returned for analysis.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.Complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The manufacturer internal reference number is: (b)(4).

Event Description

A buyer reported that during an intraocular lens (iol) implant procedure, the lens loaded into cartridge, and the plunger damaged the lens.There was no patient contact and the procedure was completed the same day.Additional information was provided that there was contact with the patient, no patient injury, and it was reported that the cartridge was not snapped into the inserter properly and the plunger overrode the lens and the lens was damaged.

Manufacturer Narrative

Product evaluation: the cartridge was not returned.The lens was returned semi-folded posterior surface up in the lens case.Viscoelastic is observed on the lens.Both haptics are folded/tucked onto the anterior optic surface.There is a small crack at the gusset area of one folded haptic.It cannot be determined if this damage occurred in the cartridge or due to the returned lens position in the lens case.No other damage is observed.The cartridge complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The root cause appears to be related to a failure to follow the directions for use (dfu).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
• MDR Report Key: 9983051
• MDR Text Key: 188667087
• Report Number: 1119421-2020-00711
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/14/2020
• Initial Date Manufacturer Received: 03/26/2020
• Initial Date FDA Received: 04/21/2020
• Supplement Dates Manufacturer Received: 06/09/2020
• Supplement Dates FDA Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL DELIVERY SYST; SN60WF.210, ACRYSOF; UNSPECIFIED DUOVISC VISCOELASTIC
• Patient Age: 69 YR