TECNIS IOL ZXT225 (REF ZXT225U105)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 10.5D 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474605602), received between Dec 27, 2018 and Dec 27, 2018 — classified as 1 injury.
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
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 27, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT A ZXT225 10.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE OF RESIDUAL MYOPIA. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 9.5. THE PATIENT WAS REPORTED AS DOING GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 8198409 ↗
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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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