TECNIS IOL ZCB00 (REF ZCB0000330)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS 1-PC CLEAR MONO 6.0MM 33.0D · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 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 05050474531970), received between Jan 9, 2017 and May 10, 2024 — classified as 1 injury, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Scratched Material1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 10, 2024Scratched Material; Scratched Material
IT WAS REPORTED THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). A SCRATCH ON THE IOL WAS SEEN UNDER THE MICROSCOPE BY THE SURGEON. THE IOL WAS REMOVED AND REPLACED WITH ANOTHER ZCB00 33.0 DIOPTER IOL DURING THE SAME PROCEDURE. THE INCISION WAS ENLARGED AND UNPLANNED SUTURES WERE REQUIRED. THE SUTURES WERE NOT USED AS A PROPHYLACTIC MEASURE. THERE WAS NO VITRECTOMY AND NO SERIOUS PATIENT INJURY WAS NOTED. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS UNKNOWN AS PATIENT HAS NOT REQUIRED RETURN TO OR AS OF (B)(6) 2024. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19288465 ↗MalfunctionJan 9, 2017Break; Break
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) BROKE DURING INSERTION INTO THE EYE. REPORTEDLY THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Information
MAUDE report 6235835 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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