TECNIS IOL ZCT450 (REF ZCT450U100)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 10.0D 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 05050474602786), received between Feb 7, 2020 and Feb 7, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Unintended Movement” (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
- Unintended Movement1
Patient problems
- Blurred Vision1
- No Code Available1
- Retinal Detachment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 7, 2020Unintended Movement; Unintended Movement
A MALE PATIENT REPORTED THAT HE WAS IMPLANTED WITH AN INTRAOCULAR LENS (IOL), MODEL ZCT450 10.0 DIOPTER IN THE RIGHT EYE (OD). ONE-DAY POST-OP, (B)(6) 2019, THE LENS HAD TO BE REPOSITIONED DUE TO A 108-DEGREE ROTATION. NO OTHER SURGICAL INTERVENTIONS AND NO PATIENT INJURY WERE REPORTED WHEN THE LENS WAS REPOSITIONED. THE PATIENT REPORTS BLURRY VISION SOMETIMES WITH SIGNS AND TELEVISION, AND HE HAS GLARE ISSUE AT NIGHT TIME WHEN DRIVING. IT WAS NOTED THAT THE SYMPTOMS ARE NOT DEBILITATING, AND HE IS ABLE TO PERFORM HIS DAILY TASKS/ACTIVITIES. THE PATIENT ALSO REPORTED THAT HE HAD DETACHED RETINA AFTER THE LENS WAS REPOSITIONED. HIS DOCTOR TOLD HIM THAT IT WAS DUE TO PATIENT¿S STRETCHED/VERY TIGHT RETINA. THE PATIENT WAS REFERRED TO A RETINA SPECIALIST WHO STITCHED HIS RETINA AND GAVE HIM GAS TREATMENT TO RESOLVE THE ISSUE. THE PATIENT ALSO REPORTS BAD ASTIGMATISM IN BOTH EYES (OD: 4.25 AND OS: 3.0). THE PATIENT WAS GIVEN PROGRESSIVE READERS TO USE FOR CLOSE RANGE AND WHEN HE IS ON COMPUTER. PRESCRIPTION FOR OD: SPHERE: +0.5, CYLINDER: -1.0, AXIS: 163 AND MAGNIFICATION: 2.5. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE PATIENT'S RIGHT EYE (OD). A SEPARATE REPOR
Patient problems: Blurred Vision; No Code Available; Retinal Detachment
MAUDE report 9684116 ↗
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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