SMARTLOAD GCB00 (REF GCB0000185)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SMARTLOAD TECNIS 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474620575), received between May 29, 2021 and Feb 27, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Appropriate Device Problem Term/Code Not Available1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Break
IT WAS REPORTED THAT DURING HANDLING AND PRIOR TO INSERTION OF THE INTRAOCULAR LENS (IOL), THE IOL WAS FOUND TO BE IN TWO PIECES WHEN SCREWING THE LENS FORWARD. A NEW IOL WAS OPENED FOR USE. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24473410 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS CHIPPED AND NOT IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23432895 ↗MalfunctionOct 28, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE LENS WAS IMPLANTED AND THEN REMOVED. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18026773 ↗MalfunctionMay 29, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PIECE OF WIRE CAME WITH THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE. THE THREAD HAS BEEN SAVED. IT WAS LEARNED THAT THE LENS IS IMPLANTED IN THE EYE, NO PATIENT INJURY EVERYTHING LOOKS FINE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11905654 ↗
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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