TECNIS IOL ZXT300 (REF ZXT300U125)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 12.5D CYL3.00 · 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 05050474606234), received between May 25, 2017 and Jan 15, 2020 — 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 Problem2
- Inadequacy of Device Shape and/or Size1
- Incorrect Measurement1
Patient problems
- No Code Available2
- Blurred Vision1
- Halo1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A SYMFONY TORIC INTRAOCULAR LENS (IOL) COMPLAINED OF RINGS AND WANTED THE IOL EXPLANTED. ADDITIONAL INFORMATION RECEIVED REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENTS LEFT EYE AND SOON AFTER SURGERY THE PATIENT COMPLAINED OF BEING VERY TROUBLED BY POSITIVE DYSPHOTOPSIA AND HALOS, AND WAS UNABLE TO DRIVE AT NIGHT. THE EXPLANTED IOL WAS EXCHANGED FOR A NON-JOHNSON AND JOHNSON IOL. THERE WERE NO COMPLICATIONS AND NO NEED FOR SUTURES. THE DAY AFTER SURGERY, THE PATIENT WAS DOING FAIRLY WELL. HE WAS 20/40 SANS CORRECTION (SC) AND SEEMS CLOSE TO EMMETROPIA. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EXCHANGE WENT WELL AND CONTINUES TO DO WELL. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Halo; No Code Available; Visual Disturbances
MAUDE report 9589800 ↗InjuryMay 25, 2017Incorrect Measurement; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Incorrect Measurement; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZXT300 12.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED BECAUSE PATIENT'S VISION WAS NOT CLEAR. PATIENT COULD NOT SEE OR READ SMALL PRINT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; No Code Available
MAUDE report 6590035 ↗
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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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