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

Catalog Number 8065977758

Device Problems Break (1069); Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2019

Event Type  malfunction  

Manufacturer Narrative

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.Root cause has not been identified.Additional information has been requested.(b)(4).

Event Description

A facility representative reported that a cartridge scratched an intraocular lens (iol).The representative also indicated that the tip of the cartridge appeared smashed.There was no patient harm or injury that occurred and the procedure was completed with a new cartridge and iol.Additional information has been requested.

Manufacturer Narrative

The reported cartridge was not returned for evaluation.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 customer indicated the use of a qualified lens, handpiece and viscoelastic.The root cause could not be determined for the lens damage.The cartridge was not returned for evaluation.The observed lens damage is similar in appearance to damage caused by an instrument used to grasp the lens (possibly loading forceps).Very little viscoelastic was observed on the lens.This may indicate a failure to follow the dfu.The dfu instructs to fill the cartridge with viscoelastic before loading the lens.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage or delivery issues.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B
• 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: 8483366
• MDR Text Key: 141170458
• Report Number: 1119421-2019-00415
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• PMA/PMN Number: K001157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977758
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH II DELIVERY SYSTEM.; OVD -VISCOAT OR PROVISC.; SA60WF 19.5D.