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 Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2019

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.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, when the surgeon was inserting the iol into the eye, he noticed that the tip of the cartridge was fractured.He was able to implant the iol without harm to the patient and no issue with the lol.Additional information has been requested.

Manufacturer Narrative

Product evaluation: the used cartridge was returned.Inadequate viscoelastic is observed in the cartridge.The cartridge has evidence that is was placed in a handpiece.The nozzle is cracked on the right side.The nozzle also has a large aneurysm in the top center.This turns into a split as it enter the tip section.Cartridge product history records were reviewed and documentation indicated the product met release criteria.The root cause may be related to a failure to follow the directions for use (dfu).The dfu instructs to fill the cartridge with viscoelastic before loading the lens.Damage was observed in the nozzle and the tip areas.This type of damage is typically progressive and worsens as the lens is advanced.The damage on the top of the nozzle started in the thick wall cone area of the nozzle.Unusually high internal forces would be needed to create damage in this area.The two distinct areas of damage would indicate a progressive change that occurred as the lens was advanced.This type of damage typically occurs if the lens is not positioned correctly for advancement; if there is a lack of viscoelastic between the lens and the cartridge lumen; if the lens is advanced too rapidly or if the handpiece plunger is not positioned correctly at the trailing optic edge.If the handpiece plunger is not positioned at the trailing optic edge it can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge, which could cause damage to the tip or the lens.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: 8689218
• MDR Text Key: 147881339
• Report Number: 1119421-2019-00862
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32661389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 07/29/2019
• Supplement Dates FDA Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(4).; MONARCH III HANDPIECE; PROVISC; UNSPECIFIED VISCOELASTIC