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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD./ HUNTINGTON MONARCH III IOL DELIVERY SYSTEM CARTRIDGE -D LENS GUIDE

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ALCON RESEARCH, LTD./ HUNTINGTON MONARCH III IOL DELIVERY SYSTEM CARTRIDGE -D LENS GUIDE Back to Search Results
Catalog Number 8065977763
Device Problems Defective Device; Injection System
Event Date 01/29/2015
Event Type  Injury  
Event Description

A healthcare worker reported that during an intraocular lens (iol) implant procedure, a cartridge opened at the tip while inside the eye. This created a hole in the posterior capsule, resulting in an unplanned anterior vitrectomy. Additional info has been requested.

 
Manufacturer Narrative

Evaluation summary: product history records were reviewed and documentation indicated the product met release criteria. The customer indicated the use of an unapproved lens with the cartridge. The intraocular lens (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 root cause may be related to a failure to follow the directions for use (dfu). Attempts have been made to obtain additional info. A completed questionnaire was received on (b)(6) 2015. (b)(4).

 
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Brand NameMONARCH III IOL DELIVERY SYSTEM CARTRIDGE -D
Type of DeviceLENS GUIDE
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
janet moran
6201 south freeway, r3-48
fort worth , TX 76134
8176152742
MDR Report Key4548640
Report Number1119421-2015-00130
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 01/29/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2019
Device Catalogue Number8065977763
Device LOT Number32329631
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received01/29/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/25/2015 Patient Sequence Number: 1
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