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 Break (1069)

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

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The iol product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.Zip code is not indicated at this time.The manufacturer internal reference number is: (b)(4).

Event Description

An ophthalmologist reported that during an intraocular lens (iol) implant procedure, the cartridge broke during the implantation process.There was no patient affected and the procedure was completed.

Manufacturer Narrative

Evaluation summary: the cartridge was returned.A small amount of viscoelastic is dried in each cartridge.The cartridge tip has heavy stress.The tip is not broken.The customer indicated the use of a non-qualified lens model.The customer indicated the use of a handpiece which is qualified for this cartridge with a qualified lens/cartridge combinations.There was no problem found with the cartridge.The cartridge was not broken.Stress lines were observed which may have been interpreted as the reported complaint.The stress lines observed are an expected occurrence with a lens delivery and do not denote a product malfunction.However, it can be more pronounced if there is an inadequate amount of viscoelastic between the lens and the cartridge lumen or if the lens is not positioned correctly.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.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 account used a lens/cartridge combination which is not qualified for use.The use of non-qualified combinations may result in delivery issues and/or 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, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7179365
• MDR Text Key: 96949729
• Report Number: 1119421-2018-00037
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

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: Other
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 8065977763
• Device Lot Number: 32553994
• Other Device ID Number: 00380659777639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 03/13/2018
• Supplement Dates FDA Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2017
• 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