Phaco fragmentation needles, 23G / 0.6 mm, incl. needle wrench. 3005.F106Recalls & reported problems
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717872016818), received between May 10, 2018 and Jun 13, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Separation” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Separation2
Patient problems
- Device Embedded In Tissue or Plaque2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2018Material Separation; Material Separation
DURING THE OPERATION THE PHACO FRAGMENTATION NEEDLES BROKE IN THE EYE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7598213 ↗InjuryMay 10, 2018Material Separation; Material Separation
SALES REP REPORTED THAT DURING MY VISIT THE DR HAS TO USE A FRAGMENTATION NEEDLE TO REMOVE A HARD LENS. TO OUR SURPRISE WE SAW SMALL PIECES OF METAL IN THE SCLEROTOMY THAT CAME FROM THE NEEDLE. SAMPLE IS AVAILABLE. ALL INFORMATION HAS BEEN DISCLOSED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7504638 ↗
Other Unit, Phacofragmentation devices
- Centurion 8065751763Alcon Laboratories, Inc. · Unit, phacofragmentation728 reports
- Centurion 8065753057Alcon Laboratories, Inc. · Unit, phacofragmentation639 reports
- CENTURION® 8065752914Alcon Laboratories, Inc. · Unit, phacofragmentation571 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751617Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls398 reports
- Alcon 8065752201Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall386 reports
- Alcon 8065752200Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall366 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751767Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls302 reports
- Constellation, ULTRAVIT, Engauge, 25+ 8065752415Alcon Laboratories, Inc. · Unit, phacofragmentation369 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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