SMARTLOAD GAB00 (REF GAB0000185)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SMARTLOAD SENSAR 1PC CLEAR MONO 18.5D · Class 3
All models of SMARTLOAD (52)
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 05050474621756), received between Mar 22, 2023 and Dec 2, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS BROKEN AND WAS NOT IMPLANTED. THROUGH FOLLOW-UP, WE LEARNED THAT THE LENS BROKE DURING PREPARATION PRIOR TO INSERTION. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23700955 ↗MalfunctionMar 22, 2023Scratched Material; Scratched Material
IT WAS REPORTED THAT UPON IMPLANTATION, AN INTRAOCULAR LENS (IOL) SHOWED A MARK AT THE EDGE OF THE OPTIC. THROUGH FOLLOW-UP WE LEARNED THAT THE IOL REMAINS IMPLANTED AND NO INTERVENTIONS WERE REQUIRED OR PLANNED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16595394 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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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