TECNIS IOL ZCT400 (REF ZCT400U225)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 22.5D 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
- 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 05050474553965), received between Jun 20, 2017 and Jul 9, 2021 — classified as 3 injuries.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Unintended Movement1
Patient problems
- No Code Available2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Capsular Bag Tear1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) FELL BACK TO BACK OF THE LEFT EYE. THE PATIENT IS NOT SATISFIED. ADDITIONALLY, THE CAPSULE IS FREE FLOATING IN THE VITREOUS. THEREFORE, THE LENS WAS EXPLANTED. AN INCISION ENLARGEMENT AND VITRECTOMY WERE REQUIRED. ANOTHER JOHNSON & JOHNSON LENS MODEL ZA9003 22.5D (DIFFERENT MODEL BUT SAME DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear
MAUDE report 12147905 ↗InjuryMay 22, 2019Unintended Movement; Unintended Movement
IT WAS REPORTED INTRAOCULAR LENS (IOL) MODEL ZCT400 22.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. IOL WILL BE EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINT OF LENS SHIFTED OFF AXIS. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING THE DOCTOR WAS ABLE TO ROTATE THE LENS BACK INTO POSITION, AND THE LENS WAS NOT EXPLANTED/EXCHANGED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: No Code Available
MAUDE report 8630521 ↗InjuryJun 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZCT400 22.5 DIOPTER INTRAOCULAR (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE DUE TO HIGH RESIDUAL ASTIGMATISM. THE LENS WAS REPLACED A DIFFERENT MODEL WITH LENS A LOWER DIOPTER SIZE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6652797 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page