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

The product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.(b)(4).

Event Description

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

Manufacturer Narrative

Additional information provided.The complaint cartridge was not returned for an evaluation.An unopened carton and six unopened pouches of company cartridges (lot number 32553994) were returned, for a total of sixteen (16) unopened samples.There were no damaged/broken cartridges observed in any of the returned samples.A photo of the side of the company 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 with the complaint cartridge.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.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/company cartridge 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 lens model, and that the company lens model listed as an approved lens model must refer to the company lens (which was used in the cartridge); however, the company lens model is a valid lens model with different dimensions than the other company lens model.The company lens has been qualified for use in the company d cartridge.The lens model indicated as used by the customer is not the correct lens model and is not qualified for use in the company d cartridge.The lens model used is only approved for use in the company b and c cartridges with only approved viscoelastic.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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7248988
• MDR Text Key: 99329784
• Report Number: 1119421-2018-00133
• 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: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 8065977763
• Device Lot Number: 32553994
• Other Device ID Number: 8065977763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other