TECNIS IOL ZCU225 (REF ZCU225U145)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 14.5D 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474658868), received between Apr 5, 2022 and Jun 12, 2025 — classified as 2 injuries.
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 Problem2
Patient problems
- Blurred Vision1
- Discomfort1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT A PATIENT EXPRESSED DISSATISFACTION WITH THEIR VISION AND SUBSEQUENTLY UNDERWENT AN INTRAOCULAR LENS (IOL) EXCHANGE IN THE RIGHT EYE (OD). IT WAS STATED THAT THE EXPLANT WAS NOT ATTRIBUTED TO ANY MALFUNCTION OF THE IOL. THERE WERE NO RECORDED PATIENT INJURIES, AND NO COMPLICATIONS SUCH AS CAPSULAR TEAR, VITRECTOMY, OR SUTURING WERE REPORTED. THE PATIENT DID NOT REQUIRE ANY MEDICATIONS BEYOND THE STANDARD OF CARE. THE LENS IS UNAVAILABLE FOR RETURN AS IT HAS BEEN DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Discomfort
MAUDE report 22198564 ↗InjuryApr 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) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO BLURRED VISION AND RESIDUAL ASTIGMATISM. PATIENT HAD KERATOCONUS. REPORTEDLY, THERE WAS NO FURTHER MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A JOHNSON & JOHNSON IOL MODEL ZCU375, 14.0 DIOPTER POWER. THE EXPLANTED IOL WAS DESTROYED BY THE CUSTOMER AND WILL NOT BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision
MAUDE report 14018245 ↗
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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