TECNIS IOL ZCT450 (REF ZCT450U235)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 23.5D 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474603059), received between Jul 11, 2018 and Jul 11, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (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.
Most reported problems
Device problems
- Unintended Movement2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2018Unintended Movement; Unintended Movement
REPORTEDLY, TECNIS TORIC ZCT450 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD). IOL WAS PLACED AT 105 DEGREES AT IMPLANT AND WAS MEASURED AT 6-MONTH STUDY VISIT ON (B)(6) 2018 AT 92 DEGREES. THE ISSUE WAS IDENTIFIED AFTER THE PROCEDURE. IT WAS NOTED THAT THERE WAS A PATIENT CONTACT, BUT THERE WERE NO PATIENT COMPLICATIONS AND NO RELATED INJURIES. PATIENT OUTCOME DOES INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE PRODUCT WILL NOT BE RETURNED AS IT REMAINS IMPLANTED. AND THERE IS NO IOL REPOSITIONING PLANNED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7679490 ↗MalfunctionJul 11, 2018Unintended Movement; Unintended Movement
REPORTEDLY, A TECNIS TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS). IOL WAS PLACED AT 72 DEGREES AT IMPLANT AND WAS MEASURED AT THE 6-MONTH STUDY VISIT ON (B)(6) 2018 AT 82 DEGREES. THE ISSUE WAS IDENTIFIED AFTER THE PROCEDURE. IT WAS NOTED THAT THERE WERE NO PATIENT COMPLICATIONS AND NO RELATED INJURIES. PATIENT OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH THE ACTIVITIES OF DAILY LIFE. THE PRODUCT WILL NOT BE RETURNED AS IT REMAINS IMPLANTED. AND THERE IS NO IOL REPOSITIONING PLANNED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7679475 ↗
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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