SMARTLOAD GAB00 (REF GAB0000100)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SMARTLOAD SENSAR 1PC CLEAR MONO 10.0D · 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 05050474621589), received between Jul 24, 2025 and May 13, 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
- 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.
MalfunctionMay 13, 2026Break
IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS BROKE DURING IMPLANTATION; THE LENS HAD BEEN PARTIALLY INSERTED AND WAS IMMEDIATELY REPLACED WITH ANOTHER LENS OF THE SAME DIOPTER. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162701 ↗MalfunctionJul 24, 2025Crack; Crack
IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) CARTRIDGE WAS BROKEN. THE INCIDENT INVOLVED CONTACT WITH THE EYE; HOWEVER, ONLY THE CARTRIDGE CONTACTED THE EYE, NOT THE LENS. THE TIP OF THE CARTRIDGE WAS NOT DAMAGED. THERE WAS NO HARM TO THE PATIENT, AND A BACKUP IOL WAS USED TO COMPLETE THE PROCEDURE. THE MATERIAL WAS RETURNED, AND THE INVESTIGATOR CONFIRMED THAT THE CRACK WAS AT THE TIP WITH NO INDICATION OF USER ERROR OR HANDLING ISSUES IDENTIFIED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22600682 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page