TECNIS IOL ZCT450 (REF ZCT450U245)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 24.5D CYL4.50 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474603073), received between Mar 2, 2018 and Mar 2, 2018 — classified as 1 injury.
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
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
INITIALLY IT WAS REPORTED THAT THERE WAS A TECNIS TORIC CALCULATOR ERROR. THE CALCULATION FOR THE INTRAOCULAR LENS CAME OUT WITH +24.5 BUT THE LENS SHOULD HAVE BEEN +14.5 OR THEREABOUTS. THROUGH FOLLOW UP IT WAS CLARIFIED THAT IT WAS NOT A CALCULATOR ERROR BUT A DATA ENTRY ERROR INTO THE CALCULATOR BY A TECHNICIAN. THE IMPLANTED LENS (MODEL ZCT450 +24.5 DIOPTER) WAS SUBSEQUENTLY EXPLANTED IN A SECONDARY PROCEDURE. AT EXPLANT, THE INCISION WAS ENLARGED AND A MODEL ZCT300 +15.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED TO BE DOING GOOD AT DISCHARGE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 7311383 ↗
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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