SMARTLOAD GCB00 (REF GCB0000150)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SMARTLOAD TECNIS 1PC CLEAR MONO 15.0D · Class 3
All models of SMARTLOAD (52)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474620506), received between Jan 6, 2026 and Jul 16, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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
- Adverse Event Without Identified Device or Use Problem1
- Device Difficult to Setup or Prepare1
- Material Fragmentation1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Toxic Anterior Segment Syndrome (TASS)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2026Device Difficult to Setup or Prepare; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25843651 ↗MalfunctionFeb 26, 2026Material Fragmentation
IT WAS REPORTED THAT DURING USE OF THE PRELOADED INTRAOCULAR LENS (IOL), THE HAPTIC WAS FOUND TO BE STUCK AT THE CARTRIDGE. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. ACCOUNT INDICATED THAT IT WAS UNKNOWN IF THE HAPTIC WAS DETACHED AND LEFT BEHIND IN THE CARTRIDGE. NO MATERIAL IS AVAILABLE TO RETURN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24464551 ↗InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POSTOPERATIVE TOXIC ANTERIOR SEGMENT SYNDROME (TASS) INFECTIONS WERE OBSERVED IN DIFFERENT PATIENTS ASSOCIATED WITH SIX DIFFERENT PRODUCT SERIAL NUMBERS. PATIENTS EXPERIENCED INFECTION, SOUGHT MEDICAL ATTENTION, AND WERE PRESCRIBED MEDICATION. ALL PATIENTS WERE REPORTED AS FULLY RECOVERED ALTHOUGH THEIR DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED DURING THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.SEPARATE REPORTS ARE BEING SUBMITTED FOR EACH PATIENT/ LENS.
Patient problems: Toxic Anterior Segment Syndrome (TASS)
MAUDE report 23985332 ↗
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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