SMARTLOAD GCB00 (REF GCB0000310)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SMARTLOAD TECNIS 1PC CLEAR MONO 31.0D · 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 05050474620827), received between Jul 9, 2021 and Jul 9, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Most reported problems
Device problems
- Material Fragmentation1
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.
MalfunctionJul 9, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE CUSTOMER SENT IN A FAX INDICATING LENS AS DEFECTIVE. NO FURTHER DETAILS WERE GIVEN. CUSTOMER SERVICE CALLED THE CUSTOMER ABOUT IT. THEY CONFIRMED THE IMPLANTATION AND EVENT DATE AS (B)(6) 2021. FOR GCB0000310 THEY REPORTED THE DEFECT AS ONE HAPTIC MISSING, THIS WAS NOTICED UPON OPENING THE PACKAGING. THEY WARE UNAWARE ABOUT THE NATURE OF THE DEFECT OF GCB0000300. THE SURGERY WAS COMPLETED WITH GCB0000305 SN (B)(4). THEY REPORTED NO ISSUES REGARDING THE PATIENT. BOTH LENSES WERE DESTROYED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12145616 ↗
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- 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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