TECNIS IOL ZCT400 (REF ZCT400U170)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 17.0D 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474553859), received between Aug 18, 2017 and Dec 2, 2019 — classified as 2 injuries, 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 Problem2
- Unintended Movement1
Patient problems
- No Code Available2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZCT400 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019, DUE TO A MISSED REFRACTION. A REPLACEMENT LENS IS A ZCT400 18.5 DIOPTER LENS (HIGHER DIOPTER). THERE WAS NO COMPLICATION OR PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 9399413 ↗MalfunctionNov 20, 2017Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE PATIENT HAD AN INTRAOCULAR LENS (IOL) IMPLANTED IN THE RIGHT EYE ON (B)(6)2017, WHERE THE IOL WAS PLACED AT 118 DEGREES. THE PATIENT RETURNED ON (B)(6) 2017, FOR THE 1-MONTH POST-OPERATIVE EXAM, AND THE IOL HAD ROTATED AND WAS AT 104 DEGREES. THE SUBJECT WAS REPORTED TO BE HAPPY WITH THEIR VISUAL OUTCOME. NO REPOSITIONING IS PLANNED. UNCORRECTED VISUAL ACUITY -RIGHT EYE = 20/25. BEST CORRECTED VISUAL ACUITY- RIGHT EYE = 20/20. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7047400 ↗InjuryAug 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN EXPLANT OF A TECNIS TORIC INTRAOCULAR LENS (IOL), MODEL ZCT400 17.0 DIOPTER, WAS PERFORMED DUE TO REFRACTIVE ERROR. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6805900 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page