TECNIS IOL ZCT400 (REF ZCT400U235)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 23.5D 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474553989), received between Aug 30, 2016 and Oct 26, 2018 — classified as 3 malfunctions.
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
- Device Contamination with Chemical or Other Material1
Patient problems
- No Consequences Or Impact To Patient2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 26, 2018Unintended Movement; Unintended Movement
IT WAS REPORTED THAT MODEL ZCT400 TECNIS TORIC IOL (INTRAOCULAR LENS) WAS INITIALLY PLACED AT 170 DEGREES IN HER LEFT EYE (OS) DURING HER SURGERY ON (B)(6) 2018. AFTER 6-MONTH VISIT ON (B)(6) 2018, IOL IS AT 15 DEGREES. IT WAS NOTED THAT SUBJECT HAD NO COMPLAINTS AND NO PATIENT INJURY REPORTED. OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. PRODUCT WILL NOT BE RETURNED AS IT REMAINS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8008099 ↗MalfunctionOct 25, 2018Unintended Movement; Unintended Movement
IT WAS REPORTED THAT TORIC (ZCT400) INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT (OD) EYE. THE IOL WAS PLACED AT 4 DEGREES DURING SURGERY ((B)(6) 2018) AND WAS MEASURED AT THE 6-MONTH VISIT ((B)(6) 2018) AT 35 DEGREES WITH A DIFFERENCE OF 31 DEGREES. SUBJECT HAD NO COMPLAINTS AT THE 6-MONTH VISIT. THERE WAS NO PATIENT INJURY/COMPLICATION. REPORTEDLY, THERE ARE NO PLANS FOR IOL REPOSITIONING. THE LENS REMAINS IMPLANTED IN THE EYE. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH THE PATIENT'S DAILY ACTIVITIES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8007833 ↗MalfunctionAug 30, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT SPECKS AND DEBRIS WERE NOTICED ON AN INTRAOCULAR LENS (IOL) BEFORE LOADING IT INTO THE CARTRIDGE. NO PATIENT CONTACT REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 5914914 ↗
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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