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); Crack (1135); Unstable (1667)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2021

Event Type  malfunction  

Manufacturer Narrative

Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during the implantation of an intraocular lens (iol) there was a clicking sound and when the lens was implanted in the eye they noticed that the second haptic was cracked.The surgery was completed with the same iol implanted in the patient's eye.The iol is still on the capsular bag, no adverse even have been noticed for the patient.It was also reported that there was a fissure in the distal part of the cartridge (nozzle tip).Additional information was received reporting the implant was unstable in the eye.The situation might require another intervention and an iol explant to replace it.The iol is still implanted.

Manufacturer Narrative

The used company cartridge was returned.Inadequate viscoelastic was observed in the cartridge.The cartridge tip is split along the top.The cartridge has evidence of placement into a cartridge.The cartridge was cleaned for further evaluation.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicted.The observed cartridge damage may be related to a failure to follow the dfu.Inadequate viscoelastic was observed in the cartridge.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 reported lens damage and observed cartridge damage may occur 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: 11893231
• MDR Text Key: 252905845
• Report Number: 1119421-2021-01115
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 380659777639
• Combination Product (y/n): N
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• 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: 15031136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ; PROVISC; ACRYSOF IQ; PROVISC
• Patient Age: 63 YR