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 Malposition of Device (2616)

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

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.Product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.The iol product history records were reviewed and documentation indicates the product met release criteria.Root cause has not been identified.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A doctor reported that a lens flipped upside down inside of a patient's eye after delivery during an intraocular lens (iol) implant procedure.The surgery was completed without product replacement.

Manufacturer Narrative

Product evaluation: the customer indicated the use of a qualified 16.5 diopter lens and handpiece.The iol product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a viscoelastic, which is not qualified for handpiece/ cartridge use.The root cause may be related to a failure to follow the directions for use (dfu).The viscoelastic indicated is not qualified for the lens/cartridge/handpiece combination used.Due to differing material properties, the use of an non-qualified viscoelastic 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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7495705
• MDR Text Key: 107708399
• Report Number: 1119421-2018-00558
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: ASKU
• Other Device ID Number: 380659777639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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