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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA 2.5 MM TRIPLE STEP FLARED PHACO NEEDLE.; PHACOEMULSIFICATION SYSTEM HANDPIECE
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D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA 2.5 MM TRIPLE STEP FLARED PHACO NEEDLE.; PHACOEMULSIFICATION SYSTEM HANDPIECE Back to Search Results
Catalog Number 3005.F25
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  malfunction  
Manufacturer Narrative
It has been requested that the instrument and fragment be returned for investigation.[(b)(4)].
 
Event Description
Surgeon reported a phaco- procedure at the (b)(6).He found during the i/a surgical step a metal-fragment on the top of the iris.He caught the fragment out and was looking for more ones.But it was just one piece.He said he had no patient harm during the surgery, also postoperative because he saw the eye next day and everything was fine.
 
Event Description
Surgeon reported a phaco- procedure at the (b)(6).He found during the i/a surgical step a metal-fragment on the top of the iris.He caught the fragment out and was looking for more ones.But it was just one piece.He said he had no patient harm during the surgery, also postoperative because he saw the eye next day and everything was fine.
 
Manufacturer Narrative
No visual or functionality test could be performed on the phaco handpiece and/or phaco needle as these were not returned for investigation.Investigation of the particle returned to dorc indicated that the material appears to be some kind of plastic/foam, rather than being made from metal.The fragment looks nothing like the material used in the construction of a phaco-needle.In addition, the fragment is also too big to fit through a phaco-needle.Hence, the fragment identified by the surgeon could not have originated from a phaco needle, and nor could it have entered the eye via the dorc phaco-needle.Based upon the available information it is concluded that the event is not attributable to the identified dorc devices.
 
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Brand Name
2.5 MM TRIPLE STEP FLARED PHACO NEEDLE.
Type of Device
PHACOEMULSIFICATION SYSTEM HANDPIECE
Manufacturer (Section D)
D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA
scheijdelveqeg 2
building 1
zuiland, NH 3214 VN
NL  3214 VN
MDR Report Key9396542
MDR Text Key168667762
Report Number1222074-2019-00045
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 Received12/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number3005.F25
Patient Sequence Number1
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