TECNIS IOL ZXT225 (REF ZXT225U270)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 27.0D 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474605930), received between Jul 27, 2018 and May 10, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Code Available2
- Capsular Bag Tear1
- Vitrectomy1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT225 +27.5 DIOPTER) WAS IMPLANTED, REMOVED AND REPLACED IN THE SAME SURGICAL PROCEDURE FROM PATIENT'S LEFT EYE BECAUSE OF A POSTERIOR CAPSULAR TEAR. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT THE INCISION WAS ENLARGED, A VITRECTOMY WAS REQUIRED AND SUTURES WERE USED DURING THIS PROCEDURE. LENS MODEL ZMA00 +26.0 DIOPTER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS REPORTED AS DOING GOOD. NO FURTHER INFORMATION PROVIDED.
Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy
MAUDE report 8602009 ↗InjuryJul 27, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT A ZXT225 27.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO THE PATIENT NOT BEING HAPPY WITH THE LENS AND WANTED TO CHANGE DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 25.0. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 7725479 ↗
Other Extended depth of focus intraocular lens devices
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- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens73 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens71 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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