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 Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Sticking (1597)

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

Event Date 01/14/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the lens was returned damaged and located between the nozzle entry area and the tip of a qualified cartridge.The cartridge was cleaned for further evaluation.The lens was removed from the cartridge during cleaning.Top coat dye stain testing was conducted with unacceptable results, as viewed by qa investigator and by qe engineer.Cartridge 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 associated handpiece and viscoelastic information was not provided.It is unknown if a qualified associated products were used.The root cause was determined to be manufacturing related.The root cause for the reported complaint is an insufficient amount of top coat coverage in the returned device.This was confirmed through top coat dye-stain testing of the returned cartridge.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

The iol in the moment to be implanted get stock in the cartridge.Upon investigation, qa noted the cartridge top coat dye stain testing yielded unacceptable results.

Manufacturer Narrative

The root cause was determined to be manufacturing related.The root cause for the reported complaint is an insufficient amount of top coat coverage in the returned device.This was confirmed through top coat dye-stain testing of the returned cartridge.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

(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: 7005612
• MDR Text Key: 91920622
• Report Number: 1119421-2017-01280
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: PM
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 8065977763
• Device Lot Number: 32446818
• Other Device ID Number: 380659777639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2018
• Date Device Manufactured: 03/17/2016
• 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
• Patient Age: 73 YR