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 PHACOEMULSIFICATION SYSTEM HANDPIECE; FEATHERLIGHT MICRO PHACO EMULSIFICATION/FRAGMENTATION HANDPIECE
  • 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 PHACOEMULSIFICATION SYSTEM HANDPIECE; FEATHERLIGHT MICRO PHACO EMULSIFICATION/FRAGMENTATION HANDPIECE Back to Search Results
Catalog Number 3002.M
Device Problems Complete Blockage (1094); Suction Failure (4039)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
It has been requested that the product be returned to the manufacturer for investigation.
 
Event Description
Phaco handpiece: aspiration was blocked.
 
Manufacturer Narrative
Based on the findings, the complaint was forwarded to our supplier for further investigation.The supplier will implement 100% inspection for debris in through holes prior to assembly and weld until evidence of proper training and controls are submitted by their component supplier.The component supplier must implement an inspection and control process to ensure thorough inspection, cleaning and descaling of hand piece components to eliminate any and all burrs or any other undesirable material remnants.In order to achieve this, the component specification was updated to reflect the requirement that all through holes will be clear of debris under 40x magnification.
 
Event Description
Phaco handpiece was blocked.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PHACOEMULSIFICATION SYSTEM HANDPIECE
Type of Device
FEATHERLIGHT MICRO PHACO EMULSIFICATION/FRAGMENTATION HANDPIECE
Manufacturer (Section D)
D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA
scheijdelveqeg 2
zuiland, netherlands 3214 VN
NL  3214 VN
MDR Report Key9468234
MDR Text Key176818021
Report Number1222074-2019-00048
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
Date FDA Received12/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number3002.M
Patient Sequence Number1
-
-