TECNIS IOL ZCU225 (REF ZCU225U170)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 17.0D CYL2.25 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474658912), received between Feb 24, 2023 and Apr 24, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND TO HAVE ONE HAPTIC BROKEN OFF AFTER IT WAS PLACED IN THE EYE. THE IOL WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. ACCOUNT INDICATED THAT THE HAPTIC WAS IN FRONT OF THE LENS ITSELF. THE IOL WAS REMOVED WITH A LENS CUTTER AND RETINAL FORCEPS, ALONG WITH THE HAPTIC. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME MODEL LENS. THERE WAS NO INJURY REPORTED. NO SURGICAL AND MEDICAL INTERVENTIONS WERE REQUIRED. NO POST-OPERATIVE ISSUES WERE REPORTED. THE PRODUCT IS NOT RETURNING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19176099 ↗MalfunctionFeb 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE ZCU225 LENS USED AND REMOVED. THE LENS CONTACTED THE PATIENT EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16439243 ↗
Other intraocular lens devices
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- 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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