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 Code Available (3191)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.The results from the product history record review 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.Attempts have been made to obtain additional information.(b)(4).

Event Description

A hospital pharmacist reported that during an intraocular lens (iol) implant procedure, during the injection of the implant, the cartridge gets broken.The iol was implanted because it was not deteriorated.There was no clinical consequence observed.Additional information was requested.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received that the procedure was a cataract extraction with intraocular lens (iol) implant.

Manufacturer Narrative

Product evaluation: the cartridge was returned.Only a small amount of viscoelastic was observed in the cartridge.The tip is heavily stressed and is split on the anterior side.The cartridge shows evidence of being placed into a handpiece.Cartridge product history records were reviewed documentation indicated the product met release criteria.The lens model and handpiece used were not provided.It is unknown if qualified products were used.Type of viscoelastic used was not provided, so it is unknown if a qualified product was used.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) since an inadequate amount of viscoelastic was observed in returned product.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: 7207057
• MDR Text Key: 98047270
• Report Number: 1119421-2018-00070
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2018

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: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 8065977763
• Device Lot Number: 32545348
• Other Device ID Number: 380659777639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/19/2018
• Supplement Dates Manufacturer Received: 01/18/2018; 03/28/2018
• Supplement Dates FDA Received: 02/15/2018; 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2017
• 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