SMARTLOAD GCB00 (REF GCB0000275)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SMARTLOAD TECNIS 1PC CLEAR MONO 27.5D · 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 05050474620759), received between Jul 12, 2024 and May 4, 2026 — 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
- Contamination1
- Ejection Problem1
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.
MalfunctionMay 4, 2026Break; Ejection Problem
IT WAS REPORTED THAT DURING PROCEDURE, THE CARTRIDGE INJECTOR SYSTEM JAMMED AND THE PRELOADED INTRAOCULAR LENS (IOL) HAPTICS BROKE. THE IOL WAS NOT IMPLANTED; HOWEVER, THE CARTRIDGE TIP WAS IN CONTACT WITH THE PATIENT'S EYE AS THE ISSUE WAS OBSERVED DURING LENS ADVANCEMENT. NO UNUSUAL RESISTANCE WAS OBSERVED DURING LENS PREPARATION. THE DOCTOR ACTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. IOL IMPLANTATION WAS SUCCESSFULLY COMPLETED USING A BACK-UP LENS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074399 ↗MalfunctionJul 12, 2024Contamination; Contamination
IT WAS REPORTED THAT THE SURGEON SAW A METAL SPLINTER BEING INJECTED INTO THE EYE AT THE SAME TIME AS THE PRELOADED INTRAOCULAR LENS (IOL) WAS INSERTED. THE SPLINTER WAS REMOVED FROM THE EYE. NO FURTHER INFORMATION ABOUT PATIENT COMPLICATIONS WERE RECEIVED. THE LENS REMAINS FULLY IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19732648 ↗
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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