TECNIS IOL ZCT400 (REF ZCT400U130)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 13.0D CYL4.00 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474553774), received between May 19, 2017 and Dec 20, 2017 — classified as 3 injuries.
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
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Code Available3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 20, 2017Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A ZCT400 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017. HOWEVER, THE LENS MOVED FROM IT'S ORIGINAL ACCESS, SO THE SURGEON WILL BE DOING A SECONDARY PROCEDURE TO ROTATE THE LENS BACK TO ITS CORRECT AXIS. THERE IS NO SET DATE FOR THE PLANNED SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.
Patient problems: No Code Available
MAUDE report 7135128 ↗InjurySep 26, 2017Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN A PATIENT'S EYE ON (B)(6) 2017, AND IT WAS NOTICED ROTATED FROM 40 DEGREES TO 105 DEGREES COUNTER CLOCKWISE ONE DAY POST-OP. THE AXIAL LENGTH WAS AVERAGE (23.93) AND THE HWTW (HORIZONTAL WHITE TO WHITE) WAS 11.78. REPORTEDLY, THE LENS WAS REPOSITIONED WITHOUT PROBLEMS ON (B)(6) 2017. THE PATIENT WAS REPORTED DOING GREAT, 20/25 AND HAPPY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6895399 ↗InjuryMay 19, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
A REPORT WAS RECEIVED THAT A MODEL ZCT400 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S OPERATIVE EYE AS THE IOL IMPLANTED WAS THE WRONG POWER FOR THE PATIENT¿S NEEDS. THERE WAS NO ISSUE WITH THE LENS. THE PATIENT NEEDED A MONO VISION; THEY WERE 20/20 AND JUST WANTED A DIFFERENT LIFESTYLE. THE EXPLANTED IOL WAS REPLACED WITH ANOTHER ZCT400 LENS OF A HIGHER DIOPTER (16.0). THERE WAS NO PATIENT INJURY.
Patient problems: No Code Available
MAUDE report 6577576 ↗
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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