TECNIS IOL ZCT225 (REF ZCT225U160)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474552654), received between Mar 6, 2017 and Dec 10, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 Problem2
- Device Dislodged or Dislocated1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Hemorrhage/Blood Loss/Bleeding1
- No Code Available1
- Zonular Dehiscence1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
REPORT OF TECNIS TORIC INTRAOCULAR LENS (IOL) DISLOCATION IN A PATIENT'S LEFT EYE, WITH PLANNED REPOSITIONING OR EXPLANT WAS RECEIVED. SUCCESSFUL EXCHANGE TOOK PLACE WHICH THE SURGEON PERFORMED A NEW MODIFIED YAMANE STYLE TECHNIQUE WITH NYLON SUTURES FOR SCLERAL FIXATION OF A ZCU225 16.5D IOL TO REPLACE THE DISLOCATED ZCT225 16.0 IOL. IT WAS CONFIRMED THAT THE DISLOCATION WAS DUE TO ZONULAR DEHISCENCE AND THAT AN ANTERIOR VITRECTOMY WAS NECESSARY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Zonular Dehiscence
MAUDE report 18298393 ↗InjuryApr 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT BLEEDING BEHIND THE LENS STARTED FOLLOWING CATARACT SURGERY. THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 8489551 ↗InjuryMar 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZCT225 16.0 DIOPTER WAS EXPLANTED DUE TO THE PHYSICIAN IMPLANTING AN INCORRECT LENS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6379676 ↗
Other LENS, INTRAOCULAR, TORIC OPTICS devices
- TECNIS IOL ZCT150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS1 recall7 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS43 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS36 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS32 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS30 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS29 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS21 reports
- TECNIS IOL DIU150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS19 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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