SMARTLOAD GCB00 (REF GCB0000085)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SMARTLOAD TECNIS 1PC CLEAR MONO 8.5D · Class 3
All models of SMARTLOAD (52)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474620377), received between Dec 12, 2025 and Dec 12, 2025 — classified as 1 malfunction.
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
- Ejection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2025Break; Ejection Problem; Break; Ejection Problem
IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENSES (IOLS) BECAME STUCK AT THE CUT, AND THE SURGEON WAS UNABLE TO SAVE THE IOLS WITHOUT DAMAGING THEM. THROUGH FOLLOW UP, WE LEARNED THAT THE EVENT DATES ARE UNKNOWN. THREE DIFFERENT PATIENTS WERE INVOLVED AND THE LENSES WERE NOT INSERTED INTO THEIR EYES. THE CUT REFERRED TO WAS THE INCISION CUT AND IT WAS NOT CLEAR IF THE LENSES WERE DAMAGED OR NOT. NO FURTHER INFORMATION WAS PROVIDED. NOTE: THIS REPORT IS FOR ONE OF THE 3 DEVICES CAPTURED IN COMPLAINT FILE (B)(4). SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER 2 DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23794651 ↗
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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