TECNIS IOL ZCB00 (REF ZCB0000325)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS 1-PC CLEAR MONO 6.0MM 32.5D · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474531963), received between Nov 20, 2016 and Mar 1, 2019 — classified as 1 injury, 2 malfunctions.
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.
Most reported problems
Device problems
- Break1
- Detachment Of Device Component1
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2019Break; Break
IT WAS REPORTED THAT +32.5 DIOPTER LENS MODEL, ZLB00 MONOFOCAL IOL (INTRAOCULAR LENS) WAS DAMAGED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8384160 ↗InjuryJun 7, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL ZCB00 +32.5 DIOPTER) WAS EXPLANTED FROM PATIENT'S OPERATIVE EYE DUE TO A DIOPTER CHANGE. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Code Available
MAUDE report 7577590 ↗MalfunctionNov 20, 2016Detachment Of Device Component; Detachment Of Device Component
IT WAS REPORTED THAT THE HAPTIC OF AN INTRAOCULAR LENS (IOL), BROKE OFF AFTER BEING PLACED INTO THE EYE. THE LENS HAD TO BE CUT OUT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6116016 ↗
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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