TECNIS IOL ZCT450 (REF ZCT450U180)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 18.0D CYL4.50 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474602946), received between Aug 9, 2017 and Aug 9, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (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
- Off-Label Use1
- Scratched Material1
Patient problems
- Corneal Edema1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2017Off-Label Use; Scratched Material; Off-Label Use; Scratched Material
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S EYE USING A NON-AMO INJECTOR/CARTRIDGE. THE LENS WAS TORN, SO IT HAD TO BE REMOVED AND REPLACED. REPORTEDLY, THE EXCHANGE DID NOT GO WELL, AS THE CUTTING TOOLS (UNKNOWN MODELS) WERE NOT WORKING WELL. THE CAPSULAR BAG WAS NOT TORN. THE INCISION HAD TO BE ENLARGED AND A LOT OF CORNEAL EDEMA OCCURRED AS A RESULT. THE DOCTOR TRIED A BACK-UP LENS, WHICH DID NOT GO IN THE EYE AS IT WAS JAMMED IN THE INJECTOR. THEY DECIDED THEN TO IMPLANT A SECONDARY LENS TYPE (MODEL AND DIOPTER UNKNOWN). THE PATIENT WAS 20/400 ONE DAY POST-OP. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Corneal Edema; No Code Available
MAUDE report 6779201 ↗
Other LENS, INTRAOCULAR, TORIC OPTICS devices
- TECNIS IOL ZCT150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS1 recall7 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS43 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS36 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS32 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS30 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS29 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS21 reports
- TECNIS IOL DIU150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS19 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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