PHACOFIT OM0551013Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · I/A Tip 45 Degree 0.3 mm Port · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474500426), received between Aug 20, 2018 and Aug 20, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Sharp Edges” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Sharp Edges1
Patient problems
- Capsular Bag Tear1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2018Sharp Edges; Sharp Edges
DURING A CATARACT EXTRACTION PROCEDURE, THE SURGERY CENTER REPORTED AN IRRIGATION/ASPIRATION(I/A) TIP IS CAUSING CAPSULAR TEARS. A BRIEF DESCRIPTION FROM THE SURGEON INDICATED THE I/A TIP HAD SLIGHTLY PICKED UP THE POSTERIOR CAPSULE AND MADE A SLIGHT TEAR. THE SURGEON INDICATED THE TIP WAS JAGGED AND NOT STRAIGHT ANYMORE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Capsular Bag Tear
MAUDE report 7799113 ↗
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- Visitec® 585278Beaver-Visitec International, Inc. · Cannula, Ophthalmic1 recall0 reports
- Vortex Surgical Inc VS0205.23Vortex Surgical, Inc. · Cannula, Ophthalmic1 recall0 reports
- Vortex Surgical Inc VS0250.25Vortex Surgical, Inc. · Cannula, Ophthalmic1 recall0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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