TECNIS IOL ZCU225 (REF ZCU225U130)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 13.0D 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
- 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 05050474658837), received between Feb 18, 2021 and Feb 18, 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
- Corneal Abrasion1
- No Code Available1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED SOME VISUAL DISTURBANCES MONTHS OUT WITH THE LENS IN THE RIGHT EYE. THE SYMPTOMS WERE DESCRIBED AS RADIAL GLARE AROUND BRIGHT LIGHTS, STARBURSTS, ESPECIALLY AT NIGHT, DESCRIBED AS RAYS OF LIGHT EMANATING FROM THE LIGHT SOURCE. IT WAS CONFIRMED THAT THERE WAS NO LOSS OF 2 OR MORE LINES OF BCVA AFTER IMPLANTATION, THAT THE PATIENT AVOIDS DRIVING AT NIGHT DUE TO SYMPTOMS, THOUGH WAS AVOIDING THIS PRIOR TO SURGERY AS WELL. THE DOCTOR INDICATED THAT A YTTRIUM-ALUMINUM GARNET (YAG) PROCEDURE WAS PERFORMED ON (B)(6) 2020, TO TREAT THE MILD POSTERIOR CAPSULE OPACIFICATION (PCO) AND THE PATIENT¿S SYMPTOMS. THE DOCTOR IS TREATING THE MILD OCULAR SURFACE DISEASE IN PATIENT AND PRESCRIBED AMBER TINTED LENSES FOR VERY SMALL RESIDUAL REFRACTIVE ERROR (0.50+0.25X62). NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Corneal Abrasion; No Code Available; Visual Disturbances
MAUDE report 11341991 ↗
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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