TECNIS IOL ZCU225 (REF ZCU225U295)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 29.5D CYL2.25 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 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 05050474659162), received between Sep 16, 2020 and Sep 16, 2020 — 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available1
- Therapeutic Effects, Unexpected1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A -4.50 TO 5.0D REFRACTIVE SURPRISE POST-OPERATIVE IN THE RIGHT EYE WITH AN INTRAOCULAR LENS (IOL). THE LENS WAS SCHEDULED FOR AN EXPLANT. THE PATIENT EXPERIENCED POOR VISUAL ACUITY. THROUGH FOLLOW-UP, IT WAS LEARNED THE LENS WAS EXPLANTED. INFORMATION WAS NOT AVAILABLE TO CONFIRM IF A VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE REQUIRED. THE REPLACEMENT LENS INFORMATION WAS ALSO NOT AVAILABLE. THE EVENT WAS UNEVENTFUL AND THE IS DOING GOOD. THE LENS IS WELL CENTERED AND PRESSURE IS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available; Therapeutic Effects, Unexpected
MAUDE report 10544518 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page