Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA EVA, COMBINED MACHINE INCLUDING LASER (SMA CONNECTOR); PHACOEMULSIFICATION/VITRECTOMY SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA EVA, COMBINED MACHINE INCLUDING LASER (SMA CONNECTOR); PHACOEMULSIFICATION/VITRECTOMY SYSTEM Back to Search Results
Model Number 8000.COM03
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Clouding, Central Corneal (2228)
Event Type  Injury  
Manufacturer Narrative
Surgeon has complained about cornea "clouding" after 25-30 minutes into a vr/ combined procedure.Initial request has been made to look at machine settings to check infusion pressure, service carried out week prior.Surgeon has noticed this cornea clouding effect for numerous months.Investigation will be started as soon as possible.
 
Event Description
Surgeon has complained about cornea "clouding" after 25-30 minutes into a vr/ combined procedure.Initial request has been made to look at machine settings to check infusion pressure, service carried out week prior.Surgeon has noticed this cornea clouding effect for numerous months.
 
Event Description
Surgeon has complained about cornea "clouding" after 25-30 minutes into a vr/ combined procedure.Initial request has been made to look at machine settings to check infusion pressure, service carried out week prior.Surgeon has noticed this cornea clouding effect for numerous months.
 
Manufacturer Narrative
A test of the eva machine was done in the field to make sure parameters were all within specifications.Subsequently, the use of hydroxypropyl methylcellulose (hpmc) eye drops was assessed by the medical team at the customer side.Conclusion: the route cause for this issue cannot be determined.A proposal was made by a medical doctor on the customer side to adopt an alternative regime for the use of dilating drops for vitrectomies.According to this doctor with this regime he does not have the problem of excessive corneal clouding.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EVA, COMBINED MACHINE INCLUDING LASER (SMA CONNECTOR)
Type of Device
PHACOEMULSIFICATION/VITRECTOMY SYSTEM
Manufacturer (Section D)
D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA
scheijdelveqeg 2
zuiland, netherlands 3214 VN
NL  3214 VN
MDR Report Key8235486
MDR Text Key133055372
Report Number1222074-2019-00004
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number8000.COM03
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/10/2019
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/24/2019
Patient Sequence Number1
-
-