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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 HANDPIECE LENS GUIDE

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ALCON RESEARCH LTD. / HUNTINGTON MONARCH III IOL DELIVERY SYSTEM HANDPIECE LENS GUIDE Back to Search Results
Catalog Number 8065977773
Device Problems IOL (Intraocular Lens) Implant; Scratched Material
Event Date 10/07/2014
Event Type  Injury  
Event Description

A pharmacist reported that during intraocular lens (iol) implantation the injector that was pushing the iol was bent and slided incorrectly scratching the iol inside the cartridge. The scratch was reported to be deep but not on the visual axis. The iol was cut and removed from the eye through an enlarged incision. Iris alteration with incarceration in the incision was reported. Another iol was implanted. The affected eye was the right eye. No further information is expected. This is one of two medical device reports being filed for this event.

 
Manufacturer Narrative

Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. Additional information has been requested but not received to date. (b)(4).

 
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Brand NameMONARCH III IOL DELIVERY SYSTEM HANDPIECE
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 Key4626169
Report Number1119421-2015-00139
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 12/18/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/23/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number8065977773
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/25/2015
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 TREATMENT DATA
Date Received: 03/23/2015 Patient Sequence Number: 1
Treatment
SW60WF, ACRYSOF SP NATURAL IQ
DUOVISC
MONARCH III "D" CARTRIDGES
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