TECNIS IOL ZCT225 (REF ZCT225U065)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 6.5D 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
- 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 05050474552463), received between Jul 24, 2019 and May 27, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (2 reports).
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
- Scratched Material2
- Dent in Material1
Patient problems
- No Code Available1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2020Scratched Material; Scratched Material
IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS SCRATCHED AND THERE WAS PATIENT CONTACT. THE IOL WAS REMOVED FROM PATIENT¿S OCULAR SINISTER (LEFT EYE) AND A NEW LENS WAS PLACED. THROUGH FOLLOW UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING AN INCISION ENLARGEMENT AND UNPLANNED SUTURE(S) WERE REQUIRED. THERE WAS NO SERIOUS PATIENT INJURY, NO UNPLANNED VITRECTOMY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF THE SAME MODEL AND DIOPTER SIZE. FURTHER INFORMATION WAS RECEIVED CONFIRMING THE PATIENT DID WELL POST PROCEDURE AND VISION WAS 20/30 POST-PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 10090466 ↗MalfunctionJul 24, 2019Dent in Material; Scratched Material; Dent in Material; Scratched Material
IT WAS REPORTED UPON OPENING ZCT225 6.5 DIOPTER INTRAOCULAR LENS (IOL) WAS NOT IN THE RESERVOIR OF THE LENS CASSETTE AND THE LENS HAD SCRATCHES AND DENTS. IT WAS ALSO REPORTED OUTCOME DOES NOT SIGNIFICANTLY INTERFERES WITH ACTIVITIES OF DAILY LIFE AND NO FURTHER INFORMATION IS AVAILABLE. THERE IS NO PATIENT CONTACT, NO SERIOUS PATIENT INJURY, NO MEDICAL COMPLICATIONS, AND THERE WAS NO SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: No Patient Involvement
MAUDE report 8821703 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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