SMARTLOAD GCB00 (REF GCB0000180)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SMARTLOAD TECNIS 1PC CLEAR MONO 18.0D · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474620568), received between Dec 12, 2024 and Sep 22, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (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
- Scratched Material1
Patient problems
- Endophthalmitis1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862464 ↗InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOLLOWING CATARACT SURGERIES, 6 OF 11 PATIENTS NOW RECEIVE TREATMENT IN THE HOSPITAL. BACTERIAL INFECTION IS SUSPECTED. PATIENT NUMBER 6 HAD BOTH EYES TREATED. THE CLINIC USED A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) FOR THESE PATIENTS, BUT THE SURGEON DOES NOT EXPECT THE IOLS TO BE THE SOURCE OF THE INFECTION. ALL OTHER EQUIPMENT USED FOR THE PROCEDURES WERE FROM OTHER SUPPLIERS. ACCOUNT INDICATED THAT THE OTHER 5 PATIENTS ARE WELL (PATIENTS WITHOUT THE INFECTION POST SURGERY). IT WAS ALSO CONFIRMED THAT ALL SURGERIES TOOK PLACE ON THE SAME DATE. OVERNIGHT HOSPITAL STAY AND MEDICAL INTERVENTIONS WERE REQUIRED. PATIENTS HAVE BEEN DIAGNOSED WITH ENDOPHTHALMITIS. NO SOURCE OF THE INFECTION HAS BEEN FOUND YET AS PER IN-HOUSE INVESTIGATION. THERE IS NO FURTHER PATIENT OUTCOME INFORMATION. THERE IS NO MATERIAL AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION PROVIDED. NOTE: SEPARATE COMPLAINTS HAVE BEEN CREATED FOR EACH OF THE 6 PATIENTS. THIS REPORT IS BEING SUBMITTED FOR PATIENT 2.
Patient problems: Endophthalmitis
MAUDE report 20919990 ↗
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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