TECNIS IOL ZCT400 (REF ZCT400U195)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 19.5D 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
- 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 05050474553903), received between Oct 21, 2016 and Dec 27, 2017 — classified as 1 injury, 1 malfunction.
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 Code Available1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 27, 2017Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE OF A (B)(6) MALE PATIENT ON (B)(6) 2017. THE LENS ORIGINALLY PLACED AT 170 DEGREES, WAS MEASURED AT 180 DEGREES ON (B)(6) 2017. REPORTEDLY, THERE ARE NO PLANS FOR IOL REPOSITIONING. THE LENS REMAINS IMPLANTED IN THE EYE. THE PATIENT IS REPORTED DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7150363 ↗InjuryOct 21, 2016Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A ZCT400 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN A FEMALE PATIENT'S RIGHT EYE ON (B)(6) 2016. AT SURGERY THE LENS WAS AT 106 DEGREES. DURING A ROUTINE MEDICAL EXAMINATION ON (B)(6) 2016, THE PHYSICIAN NOTICED THE LENS ROTATED TO 155 DEGREES, A DIFFERENCE OF 49 DEGREES. THERE WAS NO PATIENT COMPLICATIONS. THE SURGERY OUTCOME DID NOT SIGNIFICANTLY INTERFERED WITH PATIENTS ACTIVITIES OF DAILY LIFE. THE PATIENT HAD NO COMPLAINTS AT 1 MONTH POST-OP. THE LENS WAS RE- POSITIONED ON (B)(6) 2016.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 6048792 ↗
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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