SOLO OPOIA2045DRecalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · I/A HP 20 GA 45 DEG SILICONE SLV TIP · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474521049), received between Nov 23, 2020 and Jan 3, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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.
Reports received per month
Most reported problems
Device problems
- Disconnection1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2025Material Deformation; Material Deformation
CUSTOMER REPORTED THAT THE TIP OF THEIR IA HANDPIECE BROKE OFF AND REQUESTED A REPLACEMENT. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21068615 ↗MalfunctionNov 23, 2020Disconnection; Disconnection
PHACO TIP BROKE IN THE PATIENT¿S EYE WAS REPORTED. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT THE PHACO TIP IT BROKE IN THE EYE CHAMBER WHILE IRRIGATION/ASPIRATION (I/A) WAS BEING PERFORMED AFTER THE IMPLANTATION OF THE INTRAOCULAR LENS (IOL). THE SURGEON REPLACED THE TIP AND SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS GOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10882724 ↗
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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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