TECNIS IOL ZCU225 (REF ZCU225U160)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 16.0D 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474658899), received between Jan 6, 2023 and Sep 23, 2024 — classified as 1 injury, 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2024Break; Break
THE SURGERY CENTER REPORTED OF FOLDING ISSUE/BENT HAPTIC WITH TWO TORIC INTRAOCULAR LENSES (IOLS). THE EXTENT OF PATIENT CONTACT IS UNKNOWN/NOT PROVIDED. NO FURTHER INFORMATION WAS REPORTED. THIS MDR REPORT PERTAINS TO ZCU225 LENS. A SEPARATE REPORT WILL BE SUBMITTED FOR THE ZCU300 LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20276475 ↗InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED FOR A NON-JOHNSON AND JOHNSON INTRAOCULAR LENS (IOL) OF +26 .0 DIOPTER DUE TO REFRACTIVE ERROR. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. THE EXPLANTED IOL WAS DESTROYED AND WILL NOT BE RETURNED FOR EVALUATION. THE PATIENT IS DOING WELL AND NO INJURY WAS REPORTED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 16118275 ↗
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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