SMARTLOAD GAB00 (REF GAB0000200)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SMARTLOAD SENSAR 1PC CLEAR MONO 20.0D · 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 05050474621787), received between Nov 1, 2023 and Aug 6, 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
- Crack1
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.
MalfunctionAug 6, 2025Break; Break
IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS BROKEN. THROUGH FOLLOW-UP, WE LEARNED THAT THE CARTRIDGE BROKE, RESULTING IN DAMAGE TO THE OPTICAL PLATE. THE CARTRIDGE CAME INTO CONTACT WITH THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22733946 ↗MalfunctionNov 1, 2023Crack; Crack
IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS PROPERLY PLACED IN THE SHOOTER AND HANDLED NORMALLY; HOWEVER, WHEN ATTEMPTING TO IMPLANT, THE PLASTIC AT THE TIP OF THE CARTRIDGE SLIGHTLY CRUMBLED, MAKING FURTHER USE AND IMPLANTATION IMPOSSIBLE. IT IS NOT CLEAR IF IT WAS THE HANDLING OF THE CARTRIDGE OR PERHAPS THE SHOOTER THAT CAUSED THE PROBLEM. A NEW LENS FROM THE STOCK WAS IMPLANTED WITHOUT ANY ISSUES. NO FURTHER DETAILS WERE PROVIDED. THIS IS REPORT 1 OF 2. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER GAB00 UNIT WITH THE SAME ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18052394 ↗
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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