TECNIS IOL ZXT375 (REF ZXT375U180)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 18.0D CYL3.75 · 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 05050474606937), received between May 31, 2018 and Dec 1, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Inaccurate Information” (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
- Inaccurate Information1
Patient problems
- No Code Available2
- Blurred Vision1
- Visual Disturbances1
- Vitrectomy1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 1, 2018Inaccurate Information; Inaccurate Information
IT WAS REPORTED ZXT375 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2018 AND EXPLANTED ON (B)(6) 2018 DUE TO REFRACTIVE SURPRISE. THE SURGERY CENTER CONTACT STATED THE TORIC MULTIFOCAL LENS WAS UNNECESSARY, AND INDUCED MORE CYLINDER. THE ZXT375 IOL WAS EXCHANGED FOR A ZLB00 16.5 DIOPTER IOL. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING OCULAR SINISTER (LEFT EYE) IS BLURRY COMPARED TO OCULAR DEXTER (RIGHT EYE), BLURRY ISSUE WAS FIRST OBSERVED (B)(6) 2018, MORE CYLINDER POWER WAS INDUCED (B)(6) 2018, AND CLARIFIED THE TORIC MULTIFOCAL WAS UNNECESSARY DUE TO INACCURATE KERATOMETRY READINGS, TORIC CORRECTION WAS NOT INDICATED ONCE REPEAT MEASUREMENTS WERE DONE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: Blurred Vision; No Code Available
MAUDE report 8122767 ↗InjuryMay 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZXT375 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO VISUAL DISTURBANCES. A VITRECTOMY WAS REQUIRED AND IT WAS NOTED THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON SURGICAL VISION IOL. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available; Visual Disturbances; Vitrectomy
MAUDE report 7559404 ↗
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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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