SMARTLOAD GCB00 (REF GCB0000170)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SMARTLOAD TECNIS 1PC CLEAR MONO 17.0D · Class 3
All models of SMARTLOAD (52)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474620544), received between Jul 7, 2021 and Dec 27, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Contamination1
- Crack1
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 27, 2024Break; Failure to Advance; Break; Failure to Advance
A DEFECTIVE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS REPORTED. THROUGH FOLLOW UP IT WAS CONFIRMED THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21028684 ↗MalfunctionDec 10, 2024Contamination; Contamination
IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) THE SURGEON NOTICED A FOREIGN OBJECT THAT LOOKED LIKE A FIBER IN THE CARTRIDGE OF THE IOL. ACCOUNT INDICATED THAT THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20897836 ↗MalfunctionMay 9, 2023Break; Break
IT WAS REPORTED THAT THE CUSTOMER RECEIVED A DEFECTIVE INTRAOCULAR LENS (IOL). THE LENS WAS NOT IMPLANTED AND NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16899065 ↗MalfunctionJul 7, 2021Crack; Crack
IT WAS REPORTED THAT LENSES WERE PREPARED ACCORDING TO THE INSTRUCTIONS, NO HARM TO THE PATIENT. A PIECE OF CARTRIDGE HANGS ON THE CARTRIDGE TIP, IS FRAYED. THIS WAS DURING IMPLANTATION. CARTRIDGE TIP WAS IN CONTACT WITH THE EYE. THROUGH FOLLOW UP IT WAS LEARNED THAT THE LENS WAS IMPLANTED AND THERE WAS NO HARM TO THE PATIENT. THE PROBLEM WAS IDENTIFIED DURING AND AFTER IMPLANTATION. THE CARTRIDGE WAS IN CONTACT WITH THE PATIENT'S EYE. THERE IS NO EXACT EVENT DATE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12132445 ↗
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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