TECNIS IOL ZCT450 (REF ZCT450U195)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 19.5D 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474602977), received between May 17, 2017 and Jan 26, 2018 — classified as 1 injury, 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem1
- Unintended Movement1
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2018Unintended Movement; Unintended Movement
IT WAS REPORTED THAT AT THE ONE-WEEK POST-OPERATIVE VISIT ON (B)(6) 2017, THE DOCTOR MEASURED THE INTRAOCULAR LENS (IOL) AXIS IN THE RIGHT EYE AT 178 DEGREES. THE IOL WAS POSITIONED AT 8 DEGREES DURING SURGERY ON (B)(6) 2017. THERE WAS NO PATIENT COMPLICATION AND/OR RELATED INJURY. THE OUTCOME DOESN¿T SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO ACTIONS HAVE BEEN TAKEN. THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7223071 ↗InjuryMay 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER IMPLANTATION OF ZCT450 19.5 DIOPTER INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE OF A FEMALE PATIENT, THE PATIENT EXPERIENCED VISUAL DISTURBANCE. PATIENT UNDERWENT EXPLANT OF THE LENS AND ONE CORNEAL SUTURE WAS REQUIRED. THE REPLACEMENT LENS IS A MODEL ZCT400 19.0 DIOPTER. THE PATIENT IS VERY SATISFIED WITH HER VISUAL ACUITY AFTER THE IOL EXCHANGE.
Patient problems: No Code Available; Visual Disturbances
MAUDE report 6573332 ↗
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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