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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV VITRECTOMY TDC KIT 1-STEP 23G
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DUTCH OPTHALMIC RESEARCH CENTER BV VITRECTOMY TDC KIT 1-STEP 23G Back to Search Results
Catalog Number 6272.G1T
Device Problem Pressure Problem (3012)
Patient Problem Injury (2348)
Event Date 03/06/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Incident occurred during surgery, causing injury to the iris.No further information has been provided.All available information has been disclosed.This complaint has now been closed.
 
Event Description
During a vitrectomy the air pressure came out of the tip of the cutter.The iris of the patient has been damaged (torn apart) and the lens has been pushed to the endothel/forward.The control tubing for the cutter and the tubing for the suction seem to be exchanged.
 
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Brand Name
VITRECTOMY TDC KIT 1-STEP 23G
Type of Device
VITRECTOMY TDC KIT 1-STEP 23G
Manufacturer (Section D)
DUTCH OPTHALMIC RESEARCH CENTER BV
scheijdelveweg 2
zuidland, 3214V N
NL  3214VN
Manufacturer (Section G)
DUTCH OPTHALMIC RESEARCH CENTER BV
scheijdelveweg 2
zuidland, 3214V N
NL   3214VN
Manufacturer Contact
laura smith
10 continental dr
bldg 1
exeter, NH 03833
6037786929
MDR Report Key7669744
MDR Text Key113508028
Report Number1222074-2018-00231
Device Sequence Number1
Product Code HQE
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6272.G1T
Device Lot Number2000382693
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/06/2017
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 Number1
Patient Outcome(s) Other; Required Intervention;
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