TECNIS IOL ZCT400 (REF ZCT400U220)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 22.0D 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474553958), received between Aug 3, 2017 and Mar 30, 2020 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material1
- Unintended Movement1
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
- 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.
InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZCT400 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO THE PATIENT HAVING 2 DIOPTERS OF RESIDUAL CYLINDER. TARGET REFRACTION -0.18, POST-OP REFRACTION -1.50 2.00 X 126, UNCORRECTED VISUAL ACUITY (UCVA) 20/40, BEST CORRECTED VISUAL ACUITY (BCVA) 20/25, LENS LOCATION EIGHT DEGREES. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE LENS WAS REPLACED WITH A DIFFERENT MODEL LENS ZCU300 WITH A 22.0 DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 9900511 ↗InjuryNov 1, 2017Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A ZCT400 TORIC INTRAOCULAR LENS (IOL) INTRAOCULAR LENS HAD ROTATED BY 47 DEGREES AT A 3 DAY POST-OPERATIVE VISIT. THE INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017 IN THE LEFT EYE OF A (B)(6) YEAR-OLD MALE PATIENT. AT THIS TIME, THE LENS REMAINS IMPLANTED IN THE EYE AND THE PATIENT WAS REPORTED DOING WELL, HOWEVER A PLANNED RE-POSITIONING OF THE IOL IS SCHEDULED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6995288 ↗MalfunctionAug 3, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS DEBRIS ON THE INTRAOCULAR LENS (IOL). NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.
Patient problems: No Patient Involvement
MAUDE report 6765586 ↗
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 13, 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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