TECNIS IOL ZCT450 (REF ZCT450U200)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 20.0D 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
- 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 05050474602984), received between Apr 26, 2017 and Dec 12, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Incorrect Measurement” (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
- Incorrect Measurement1
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A ZCT450 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE ON (B)(6) 2018. THE LENS WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO RESIDUAL ASTIGMATISM DESPITE THE LENS BEING A TORIC LENS, THE PATIENT STILL HAD AS MUCH ASTIGMATISM AS BEFORE THE TORIC LENS WAS IMPLANTED. THE ZCT450 WAS REPLACED WITH A PCB00 21.0 DIOPTER IOL. THE PATIENT IS REPORTED TO BE DOING WELL POST EXCHANGE. CUSTOMER INDICATED THAT THE COMPLAINT PRODUCT WILL NOT BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 8154162 ↗InjuryApr 26, 2017Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT A ZCT450 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE FROM A MALE PATIENT'S OPERATIVE EYE DUE TO LENS CALCULATIONS OVER CORRECTED. THE LENS WAS REPLACED WITH A MODEL ZCT300 16.0 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO CAPSULE TEAR. THE PATIENT IS RECOVERING WELL.
Patient problems: No Code Available
MAUDE report 6521307 ↗
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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