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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V. 2.4 MM DISPOSABLE PHACO SET WITH 30° STRAIGHT FLARED NEEDLE; PHACOEMULSIFICATION SYSTEM HANDPIECE TIP, SINGLE-USE
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D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V. 2.4 MM DISPOSABLE PHACO SET WITH 30° STRAIGHT FLARED NEEDLE; PHACOEMULSIFICATION SYSTEM HANDPIECE TIP, SINGLE-USE Back to Search Results
Catalog Number 8430.24SF1
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/19/2024
Event Type  malfunction  
Event Description
We have been informed that during phaco surgery, the surgeon noticed metal chips( particles) in the anterior chamber.He was able to remove all particles.Surgery could proceed by using another phaco tip.In the surgeon's opinion, the particles came from the phaco tip.No report that actual patient harm occurred, also the surgery wasn't prolonged > 30 minutes.
 
Manufacturer Narrative
The complaint is under investigation.In case of a product return, the device will be investigated, otherwise we will review the device history record, and/or any log files if available, or try to replicate the problem on similar product.As investigations on the actual product or representative sample of a batch may alter the device, we request to inform us within 7 days after submission of this report, in case the investigations that alter the device should be halted until approval of the nca, as per article 89 of eu-mdr.
 
Event Description
We have been informed that during phaco surgery, the surgeon noticed metal chips( particles) in the anterior chamber.He was able to remove all particles.Surgery could proceed by using another phaco tip.In the surgeon's opinion, the particles came from the phaco tip.No report that actual patient harm occurred, also the surgery wasn't prolonged > 30 minutes.
 
Manufacturer Narrative
Unfortunately, neither the involved phaco needle, nor the metal chips that were detected and removed from the eye by the physician were sent to dorc for investigation.As no material was returned, any physical examination as to determine the origin of the chips could not be performed.Device history record review pertinent to lot 22846-1 revealed no deviations and a database search showed that no similar complaints have been reported on this specific lot prior to this case or since.A few similar complaints have been received on phaco needles from other lots, but in none of these cases it could be confirmed that the particles did, in fact, originate from the phaco needle.Based on the investigation performed, no (manufacturer related) product failure could be confirmed.The risk identified is included in the risk management documentation.Trend analysis indicates that the product is performing within anticipated rates.Complaints will be closely monitored to identify any significant adverse trends.Since no (manufacturer related) product failure could be confirmed, any remedial action/corrective action/preventive action/field safety corrective action (fsca) was deemed not necessary.The analysis includes all complaints with failure mode as reported ph-needle-particles (including case-(b)(4) ) and the combined sales figure of all phaco neeldes.
 
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Brand Name
2.4 MM DISPOSABLE PHACO SET WITH 30° STRAIGHT FLARED NEEDLE
Type of Device
PHACOEMULSIFICATION SYSTEM HANDPIECE TIP, SINGLE-USE
Manufacturer (Section D)
D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V.
scheijdelveweg 2
zuidland, 3214 VN
NL  3214 VN
Manufacturer (Section G)
D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V.
scheijdelveweg 2
zuidland, 3214 VN
NL   3214 VN
Manufacturer Contact
petra holland
scheijdelveweg 2
zuidland, 3214 -VN
NL   3214 VN
MDR Report Key18835335
MDR Text Key337309707
Report Number1222074-2024-00005
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8430.24SF1
Device Lot Number22846-*-*-1
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/05/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/26/2024
Was Device Evaluated by Manufacturer? Yes
Type of Device Usage Initial
Patient Sequence Number1
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