TECNIS IOL ZCT400 (REF ZCT400U105)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 10.5D 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474553729), received between Jan 4, 2018 and Jul 28, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 Problem1
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Code Available2
- Blurred Vision1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RECEIVED REPORT INDICATING THE IOL WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO HYPEROPIC SURPRISE POST SURGERY. THE PATIENT EXPERIENCED VERY BLURRY VISION AT BOTH DISTANCE AND NEAR. THEIR VISUAL ACUITY PRE-OP IS 20/25 WITH CORRECTION AND POST-OP IS 20/70+. THE INCIDENT DATE WAS REPORTED AS (B)(6) 2020 AND HYPEROPIA WAS CONFIRMED (B)(6) 2020. WHEN THE IOL WAS EXPLANTED THE INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. THE IOL WAS REPLACED WITH ANOTHER IOL MODEL ZCT400, BUT HIGHER DIOPTER 14.0. THIS LENS REMAINS IMPLANTED IN THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; No Code Available
MAUDE report 10334910 ↗InjuryJan 4, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT A ZCT400 10.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO IT BEING THE WRONG POWER. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 7166620 ↗
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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