TECNIS IOL ZXT225 (REF ZXT225U090)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 09.0D 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474605572), received between Jan 29, 2018 and Oct 31, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (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
- Difficult to Insert1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- 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.
InjuryOct 31, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO A PATIENT¿S RIGHT EYE AND THE DOCTOR NOTICED THAT THE LENS WAS NOT SEATED PROPERLY IN THE EYE. THE DOCTOR WANTED TO USE A 3-PIECE (3PC) LENS INSTEAD. IT WAS INDICATED THAT A VITRECTOMY WAS PERFORMED AND ANOTHER JOHNSON AND JOHNSON LENS, MODEL ZMA00, 9.0 DIOPTER 3PC WAS USED AS A REPLACEMENT. IT WAS CONFIRMED THAT THE LENS WAS REMOVED AND REPLACED DURING THE SAME INITIAL SURGERY. THE ACCOUNT INDICATED THAT IT IS UNKNOWN IF CAPSULE TEAR OCCURRED, AND IF THE PATIENT HAD ANY PRE-EXISTING ISSUES/ANATOMY ISSUES WHICH CONTRIBUTED TO THE REPORTED EVENT. THERE WERE NO OTHER SURGICAL INTERVENTIONS AND NO PATIENT INJURY WAS REPORTED. THE PATIENT IS DOING FINE POST-OPERATION. THE LENS WILL NOT BE RETURNED AS PER ACCOUNT, IT WAS DROPPED ON FLOOR AND GOT LOST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15705447 ↗MalfunctionJan 29, 2018Scratched Material; Scratched Material
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPERFECT AS THERE WERE SCRATCHES ON THE LENS. NO PATIENT CONTACT OR INJURY WAS REPORTED. ANOTHER LENS SAME MODEL AND DIOPTER WAS USED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7226988 ↗
Other Extended depth of focus intraocular lens devices
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- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens89 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens87 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens75 reports
- 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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