TECNIS IOL ZXT300 (REF ZXT300U290)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 29.0D 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 05050474606562), received between Feb 28, 2017 and Aug 28, 2018 — classified as 2 injuries.
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
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Code Available2
- 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.
InjuryAug 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT CUSTOMER WAS HAVING MECHANICAL COMPLICATION WITH ZXT300 MULTIFOCAL INTRAOCULAR LENS (IOL). THE PATIENT WAS ALSO EXPERIENCING VISUAL DISTURBANCE AND HALOS/GLARE. FOR THOSE REASONS, IOL HAD TO BE EXPLANTED AND REPLACED WITH ZKB295 LENS FROM HER RIGHT EYE (OD). IT WAS NOTED THAT PATIENT OUTCOME DID INTERFERE WITH ACTIVITIES OF DAILY LIFE, BUT PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Halo; No Code Available; Visual Disturbances
MAUDE report 7822311 ↗InjuryFeb 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZXT300 29.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED AND EXCHANGED FOR A LOWER DIOPTER (26.5) LENS OF THE SAME MODEL. THROUGH FOLLOW UP WITH THE SURGERY CENTER IT WAS CONFIRMED THAT THE POSTOP REFRACTION WAS NOT WHAT WAS EXPECTED. THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT¿S MEASUREMENTS WERE: PRE-OP RX +4.25 -1.00 X 177, POST-OP -1.75 -0.50 X 60. AT ONE (1) WEEK POST IOL EXCHANGE THE PATIENT WAS RX -0.25 -1.00 X140 ADD: +2.75 NEAR: J2@16" FAR: 20/30 VISUAL ACUITY. THE PATIENT WILL CONTINUE TO BE FOLLOWED AS THE PATIENT IS SAYING THAT THEIR VISION IS BETTER SOME BUT STILL NOT GREAT.
Patient problems: No Code Available
MAUDE report 6363435 ↗
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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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