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 Problems Break (1069); Scratched Material (3020)

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

Event Date 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.The 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 product investigation could not identify a root cause.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, the lens was scratched.The surgery was completed with a back up lens.According to the surgeon's opinion, the injector caused or contributed to the event.Additional information was provided indicating that the iol was damaged during delivery through the cartridge.Two paracentral cracks were visable in the optic after delivery in the eye.The iol was removed and replaced with another.

Manufacturer Narrative

Evaluation summary: the cartridge was not returned for analysis.The lens was returned with extensive damage.The lens was in two pieces typical of a removal.The iol product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a viscoelastic, which is not qualified for this lens/cartridge combination used.The root cause may be related to a failure to follow the directions for use (dfu).Due to differing material properties, the use of a non-qualified viscoelastic may result in delivery issues and/or damage.Lens damage during delivery typically occurs if the lens is not positioned correctly/folded correctly for advancement; if there is a lack of viscoelastic between the lens and the cartridge lumen; and/or if the handpiece plunger is not positioned correctly at the trailing optic edge.This can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge causing damage.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: 8451313
• MDR Text Key: 139972607
• Report Number: 1119421-2019-00354
• 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: foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III HANDPIECE; PROVISC; SN6AT3.225 DIOPTER