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 Torn Material (3024)

Patient Problem No Information (3190)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Complaint history and 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 has not been identified.Attempts have been made to obtain additional information.(b)(4).

Event Description

A surgeon reported that during an intraocular lens (iol) implant procedure, a trailing haptic was torn off by the inserter.The iol was cut out and removed, a new lens inserted, and a vitrectomy was performed.Additional information was requested.

Manufacturer Narrative

Based on additional information, the suspect device was noted to be a handpiece, therefore a new initial report with mfg# 2523835-2017-00493 has been filed, to reflect the case being against the handpiece and not against the cartridge as had been reported previously.(b)(4).

Event Description

Additional information was provided by a customer representative which indicates that the suspect product is not a cartridge, as reported initially.The suspect product is a handpiece.

• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6463729
• MDR Text Key: 71882990
• Report Number: 1119421-2017-00483
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: ASKU
• Other Device ID Number: 00380659777639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2017
• 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
• Treatment: UNSPECIFIED MONARCH DELIVERY SYSTEM
• Patient Outcome(s): Other; Required Intervention