TECNIS IOL ZCU450 (REF ZCU450U155)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 15.5D 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 05050474663015), received between Apr 1, 2026 and Apr 1, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A NON PRELOADED TORIC INTRAOCULAR LENS (IOL) IMPLANTED IN THE PATIENT¿S RIGHT EYE WAS EXPLANTED DUE TO POST OPERATIVE BLURRY VISION AND PATIENT DISSATISFACTION. THE ISSUE WAS IDENTIFIED DURING A POST OPERATIVE EXAMINATION. THE IMPLANTED TORIC IOL WAS CONSIDERED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AS THE PATIENT WAS DETERMINED TO BE OVER CORRECTED. A LENS EXCHANGE WAS PERFORMED, AND THE ORIGINAL IOL WAS REPLACED WITH AN ODYSSEY DRT250 +15.5 DIOPTER IOL. THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS, AND NO UNPLANNED SURGICAL INTERVENTIONS (SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES) WERE REQUIRED. AT THE TIME OF REPORTING, THE FINAL OUTCOME FOLLOWING THE LENS EXCHANGE HAD NOT YET BEEN DETERMINED, AS IT WAS TOO EARLY TO ASSESS; POST OPERATIVE REFRACTION AFTER THE EXCHANGE HAS NOT YET BEEN PERFORMED. PRE-OPERATIVELY, THE PATIENT¿S REFRACTION WAS -2.25 +3.50 × 021 WITH A BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) OF 20/40. THE INTENDED TARGET REFRACTION WAS PLANO (0.00). POST OPERATIVELY, WITH THE TECNIS TORIC IOL, THE PATIENT¿S UNCORRECTED VISUAL ACUITY WAS 20/40 AND WAS CORRECTABLE TO 20/20, INDICATING NO LOSS OF TWO OR MORE LINES OF BSCVA
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 24761206 ↗
Other intraocular lens devices
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- 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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