DORC VFI connector between DORC System & 1363.DD 1365Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717872007250), received between Oct 14, 2017 and Jun 1, 2018 — classified as 4 malfunctions.
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
- Break1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
(B)(4). PROBLEM: BLADE WAS DIRT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7562907 ↗MalfunctionJun 1, 2018Material Separation; Material Separation
DURING THE PAST WEEK, WE EXPERIENCED A NEW 1363.DD EXPLODED. THIS LOT NUMBER IS NOT ONE OF THOSE YOU HAPPENED TO RECALL IN 2015. SAMPLE IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7562674 ↗MalfunctionJun 1, 2018Material Separation; Material Separation
DURING THE PAST WEEK WE EXPERIENCED A NEW 1363.DD EXPLODED. THIS LOT NUMBER IS NOT ONE OF THOSE YOU HAPPENED TO RECALL IN 2015. SAMPLE IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7562579 ↗MalfunctionOct 14, 2017Break; Break
A REPORT HAS BEEN RECEIVED FROM (B)(6). SPRAY HAS BEEN BROKEN DURING INJECTION. CAN YOU CHECK IF NO EXCESSIVE PRESSURE IS APPLIED TO THE SYRINGE DURING INJECTION? WE HAVE A PROBLEM THIS TIME. THERE IS NO INFORMATION OF PATIENT INJURY, NO MORE AVAILABLE INFORMATION, AND THE SAMPLE HAS BEEN DISCARDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6950400 ↗
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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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