TECNIS IOL ZCT400 (REF ZCT400U120)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 12.0D CYL4.00 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 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 05050474553750), received between Apr 3, 2017 and Dec 29, 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 18, 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
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED ANSIOMETROPIA AFTER THE IMPLANTATION OF A MODEL ZCT400 12.0 DIOPTER TECNIS TORIC IOL (INTRAOCULAR LENS). THE LENS WAS EXPLANTED AND REPLACED WITH A MODEL ZCT225 12.5 DIOPTER LENS. PATIENT WAS DOING WELL POST EXCHANGE. IT WAS NOTED THAT THERE WERE NO INCISION ENLARGEMENT, NO SUTURE AND NO VITRECTOMY REQUIRED. VISUAL ACUITY PRE-INITIAL IMPLANT: 20/400; VISUAL ACUITY POST-INITIAL IMPLANT: 20/60-1; VISUAL ACUITY POST-REPLACEMENT:20/20. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Code Available; Visual Disturbances; Visual Impairment
MAUDE report 8205382 ↗MalfunctionApr 3, 2017Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE OF A (B)(6) FEMALE PATIENT. THE IOL, INITIALLY PLACED AT 108 DEGREES, WAS MEASURED AT THE SIX-MONTH POST-OPERATION VISIT AT 96 DEGREES, WITH A DIFFERENCE OF 12 DEGREES. REPORTEDLY, THERE WERE NO PATIENT OR DOCTOR COMPLAINTS AND THE BCDVA (BEST-CORRECTED DISTANCE VISUAL ACUITY) WAS 20/20 ON BOTH EYES. A TECNIS TORIC ROTATION, FOR THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE, WAS ALSO REPORTED. A SECOND MDR WILL BE FILED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6455388 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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