Phaco emulsification handpiece. 3002Recalls & 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 08717872008851), received between Oct 24, 2017 and Apr 3, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K190875); they may or may not involve this specific model.
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
- Infusion or Flow Problem1
- Insufficient Device Problem Information1
Patient problems
- Eye Burn1
- Intraocular Pressure, Delayed, Uncontrolled1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2018Infusion or Flow Problem; Infusion or Flow Problem
THE EVENT OCCURRED IN (B)(6). WE RECEIVED A REPORT OF THE FOLLOWING: IRRIGATION PRESSURE WASN'T ENOUGH SO DURING SURGERY THE EYE COLLAPSED SEVERAL TIMES. TRIED TO RINSE THE HAND PIECE WITH PRESSURE TO LOOSEN THE BLOCKAGE, BUT THAT DID NOT HELP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE/PACK.
Patient problems: Intraocular Pressure, Delayed, Uncontrolled
MAUDE report 7392784 ↗InjuryOct 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
A REPORT HAS BEEN RECEIVED OF AN INCIDENT OCCURRING IN (B)(6). CORNEA BURNT RIGHT AFTER THE START OF SCULPTURE MODE. IT WAS REPORTED THE SURGEON IMMEDIATELY AND EMERGENTLY STOPPED THE PHACO SURGERY.
Patient problems: Eye Burn
MAUDE report 6973727 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K190875. One submission often covers many models, so check the product and lot details in each record.
- Z-2252-2021 · May 21, 2019 · Open, ClassifiedThe device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.
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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