TECNIS IOL ZCU225 (REF ZCU225U210)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 21.0D 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 05050474658998), received between Aug 28, 2020 and May 3, 2021 — 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.
Most reported problems
Device problems
- Break1
- Difficult to Advance1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Vitrectomy1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 3, 2021Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn
RECEIVED REPORT INDICATING THAT THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED IN THE PATIENT¿S LEFT EYE BUT THE IOL WAS TORN. THE PARTIALLY INSERTED LENS WAS REMOVED AND REPLACED WITHIN THE SAME PROCEDURE AND REPLACED WITH A BACKUP IOL OF THE SAME MODEL AND DIOPTER. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. REPORTEDLY, THE PATIENT HAS RECOVERED. IT WAS CONFIRMED THAT THE PRODUCT WAS DISCARDED. NO MORE INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11766575 ↗InjuryAug 28, 2020Break; Break
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S RIGHT EYE BUT WAS NOTICED TO BE SCRATCHED. THEREFORE, THE LENS WAS REMOVED AND REPLACED WITH A DIFFERENT MODEL ZA9003 19.5 DIOPTER IOL. VITRECTOMY AND SUTURES WERE REQUIRED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available; Vitrectomy
MAUDE report 10467469 ↗
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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