TECNIS IOL ZCU450 (REF ZCU450U150)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 15.0D 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 05050474663008), received between Sep 17, 2021 and Jul 5, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL), MODEL ZCU450 WITH 15.0 DIOPTER POWER, WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. THE IOL WAS EXPLANTED IN A SEPARATE SURGICAL PROCEDURE AND REPLACED WITH A ZCU150 MODEL LENS WITH 15.5 DIOPTER POWER DUE TO VISUAL IMPAIRMENT THAT WAS FIRST IDENTIFIED DURING POST-OPERATIVE EXAMINATION. IT WAS REPORTED THAT THE PATIENT WAS TEMPORARILY IMPAIRED. ACCOUNT INDICATED THAT THERE WERE NO COMPLICATIONS, SUCH AS CAPSULAR TEAR, NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), AND NO VITRECTOMY DURING THE IOL EXPLANT PROCEDURE. PATIENT OUTCOME POST-LENS EXCHANGE IS UNKNOWN. IT IS ALSO UNKNOWN IF THE PATIENT IS STILL TEMPORARILY IMPAIRED POST-LENS EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Disturbances
MAUDE report 14921580 ↗InjurySep 17, 2021Break; Break
IT WAS REPORTED THAT EVENT OF BENT OR BROKEN HAPTIC OBSERVED. THERE WAS PATIENT CONTACT. THE INCISION WAS ENLARGED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12492921 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page