TECNIS IOL ZCT450 (REF ZCT450U145)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 14.5D 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 05050474602878), received between Jul 6, 2017 and Dec 12, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Positioning Problem” (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
- Positioning Problem1
- Unintended Movement1
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2018Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE ZCT450 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE (OD) ON (B)(6) 2018. ONE WEEK POST-OP IT WAS REPORTED THE LENS ROTATED 10 DEGREES COUNTER-CLOCKWISE AND VISUAL ACUITY WAS 20/70. THROUGH FOLLOW UP, CUSTOMER CONFIRMED THAT THE PATIENT DID NOT HAVE ANY HEALTH RELATED ISSUE AND/OR MEDICATIONS THAT COULD HAVE CONTRIBUTED TO THE ZCT450 ROTATION. ALTHOUGH THERE WAS MINIMAL ROTATION COUNTER CLOCKWISE AGAIN, THE PATIENT HAS ELECTED TO WEAR PRESCRIPTION GLASSES BECAUSE IT CORRECTS TO 20/20 OD WITH REFRACTION OF -1.00 +1.25 X 045. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: No Code Available
MAUDE report 8158340 ↗MalfunctionJul 6, 2017Positioning Problem; Positioning Problem
THE INTRAOCULAR LENS (IOL) WAS PLACED IN THE LEFT EYE AT 180 DEGREES AND WAS MEASURED AT A ROUTINE 1 DAY POST-OPERATIVE VISIT AT 35 DEGREES WITH A DIFFERENCE OF 145 DEGREES. IT WAS REPORTED THAT THE VISION IN THE LEFT EYE DOESN'T SEEM AS GOOD AS IN THE RIGHT EYE. THE PATIENT DOES NOT WANT REPOSITIONING AND IS OK WITH WEARING GLASSES. NO PATIENT COMPLICATIONS OR RELATED INJURIES. THE OUTCOME DOESN'T SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.
Patient problems: No Code Available
MAUDE report 6691677 ↗
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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