TECNIS IOL ZXT375 (REF ZXT375U240)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 24.0D 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474607057), received between Mar 14, 2017 and Apr 1, 2020 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
Patient problems
- No Code Available3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO HYPEROPIA AND THE REFRACTIVE OUTCOME WAS NOT OBTAINED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: No Code Available
MAUDE report 9914455 ↗MalfunctionDec 20, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT A ZXT375 24.0 DIOPTER INTRAOCULAR LENS (IOL) DISLOCATED, DATE UNKNOWN, AND WASN''T IN THE INCORRECT POSITION. THEREFORE, THE PATIENT RETURNED ON (B)(6) 2017, TO HAVE THE LENS REPOSITIONED. HOWEVER, DURING THE SURGERY THE SURGEON DECIDED TO EXPLANT THE LENS. THERE WAS VITREOUS LOSS REPORTED, NO ENLARGEMENT, AND NO OTHER PATIENT INJURY. LENS WAS REPLACED WITH A DIFFERENT LENS, THE MODEL AND DIOPTER WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 7135309 ↗InjuryMar 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZXT375 24.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN A MALE PATIENT¿S RIGHT EYE ON (B)(6) 2017. HOWEVER, THE PATIENT IS RETURNING TO HAVE THE LENS REPLACED WITH 20.0 DIOPTER SIZE LENS.
Patient problems: No Code Available
MAUDE report 6404588 ↗
Other Extended depth of focus intraocular lens devices
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens101 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens1 recall49 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens93 reports
- 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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