TECNIS IOL ZCU450 (REF ZCU450U215)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 21.5D CYL4.50 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 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 05050474663138), received between Feb 23, 2021 and Feb 23, 2021 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH AN INTRAOCULAR LENS (IOL) HAD POSTOPERATIVE REFRACTION HAS 3 DIOPTERS OF RESIDUAL ASTIGMATISM AT 83 DEGREES. THE LENS HAS NOT ROTATED AND THE PREOPERATIVE TESTING, TOPOGRAPHY, AND BIOMETRY WERE CONSISTENT WITH THE RECOMMENDED IOL IMPLANT. THE PATIENT HAS AN UNUSUAL CORNEA WITH A HIGH AMOUNT OF POSTERIOR CORNEAL CYLINDER. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE LENS WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE. AND IT WAS CONFIRMED THERE WAS NO LENS ROTATION. A NEW MONOFOCAL LENS WAS IMPLANTED AS A REPLACEMENT. IT WAS REPORTED EVENT MAYBE ATTRIBUTED TO THE PATIENT'S UNUSUAL CORNEA. THE PATIENT IS SEEING GREAT. 20/25 ON POST-OPERATIVE DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 11367061 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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