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 Type  malfunction  

Manufacturer Narrative

Evaluation summary: fourteen (14) unopened pouches of lot number 32560021 were returned for evaluation (transported in an opened carton lot number: 32552376.Samples were evaluated.There were no damaged or broken cartridges observed.A photo of the side of the monarch carton was provided.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a non-qualified lens model and non-qualified viscoelastic.The lens model indicated is only approved for use in the company b and c cartridges with only approved viscoelastic.The 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.Root cause: the reported damage could not be verified because the used company (d) cartridge was not returned.The root cause for the reported damage is most likely related a failure to follow the dfu.The account used a lens/monarch combination which is not qualified for use.The use of non-qualified combinations may result in delivery issues and/or damage.In addition, the viscoelastic indicated is not qualified for the associated lens model with qualified company combinations.Due to differing material properties, the use of a non-qualified viscoelastic may result in delivery issues and/or damage.A photo is attached of the side of the company d carton.Information in the file attachment indicated what appears to be a customer misunderstanding involving an assumption that there is no company a lens model, and that the company b lens model listed as an approved lens model must refer to the company c (which was used in the cartridge); however, the company b lens model is a valid lens model with different dimensions than the company c lens model.The company b has been qualified for use in the company c cartridge.The lens model indicated as used by the customer is an company b lens model and is not qualified for use in the company d cartridge.The company b lens model is only approved for use in the company b and c cartridges with only approved viscoelastic.The manufacturer internal reference number is: (b)(4).

Event Description

A doctor of ophthalmology reported that a cartridge broke during the intraocular lens implanting process.Additional information has been requested.

• 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: 7465678
• MDR Text Key: 106847917
• Report Number: 1119421-2018-00474
• 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
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 8065977763
• Device Lot Number: 32560021
• Other Device ID Number: 380659777639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2018
• Date Device Manufactured: 08/16/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other