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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV DISPOSABLE UNIVERSAL SILICONE INFUSION LINE FOR 23 GAUGE / 0.6 MM CANNULA SYSTEM

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D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV DISPOSABLE UNIVERSAL SILICONE INFUSION LINE FOR 23 GAUGE / 0.6 MM CANNULA SYSTEM Back to Search Results
Catalog Number 1279.IA
Device Problem Infusion or Flow Problem
Event Date 01/15/2015
Event Type  Malfunction  
Manufacturer Narrative

This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research (b)(4)). Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6) 2017. Assuming worst case during surgery, no irrigation or less irrigation may lead to hypotony therefore is deemed as reportable. No sample was returned, therefore unable to confirm this complaint. All available information has been provided. This complaint has now been closed.

 
Event Description

A report has been received from an event that occurred in (b)(6). The following has been reported: " no or minimal irrigation from the infusion line during surgery. During priming there was normal irritation. ".

 
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Brand NameDISPOSABLE UNIVERSAL SILICONE INFUSION LINE FOR 23 GAUGE / 0.6 MM CANNULA SYSTEM
Type of DeviceDISPOSABLE UNIVERSAL SILICONE INFUSION LINE FOR 23 GAUGE / 0.6 MM CANNULA SYSTEM
Manufacturer (Section D)
D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV
scheijdelveweg 2
zuidland, netherlands
NL 
Manufacturer (Section G)
D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV
scheijdelveweg 2
zuidland, netherlands
NL 
Manufacturer Contact
laura smith
10 continental dr
exeter , NH 03833
6037538824
MDR Report Key7359485
Report Number1222074-2018-00048
Device Sequence Number1
Product CodeKYG
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial
Report Date 01/15/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/21/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue Number1279.IA
Device LOT Number2000355594
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/15/2018
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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