MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Catalog Number 8065977763

Device Problem Torn Material (3024)

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

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the device was not returned for evaluation.Complaint history and monarch 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.Root cause has not been identified.Additional information has been requested.(b)(4).

Event Description

A customer reported cartridge split during an intraocular lens (iol) implant procedure.Additional information was requested.

Manufacturer Narrative

Additional information provided.Cartridge product history records were reviewed and documentation indicates the product met release criteria.The lens product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The cartridge was returned in a bag with the opened peel pouch.Only a small amount of solution was observed dried in the cartridge.The tip is heavily stressed.The anterior right side is cracked, starting prior to the parting line.The crack extended into an aneurysm that has torn and split through the tip end.The cartridge wings show evidence of being placed into a handpiece.The cartridge cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of an intraocular lens.The lens model has been qualified for use in the cartridge within the diopter range of 6.0 to 27.0.Without the associated lens diopter it cannot be determined if this is a qualified combination.Intraocular lens (iol) 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 handpiece and viscoelastics.The reported tip damage was observed.The root cause for the damage may be related to a failure to follow the directions for use (dfu).An inadequate amount of viscoelastic was observed.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 viscoelastic, which may result in damage or delivery issues.The damage observed to the tip of the used cartridge 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.(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, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7434621
• MDR Text Key: 105881807
• Report Number: 1119421-2018-00418
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 8065977763
• Device Lot Number: 32582021
• Other Device ID Number: 380659777639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other