TECNIS IOL ZXT375 (REF ZXT375U235)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 23.5D 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 05050474607040), received between Feb 13, 2017 and Jul 18, 2019 — 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 Problem1
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Code Available2
- Visual Disturbances1
- Vitreous Floaters1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE IS A PLAN TO EXCHANGE AN INTRAOCULAR LENS (IOL) FOR A PATIENT WHO INITIALLY REPORTED VISUAL ACUITY IS IMPROVING BUT COMPLAINED OF FLOATERS AND VAILS, LIKE TRYING TO LOOK THROUGH BLINDS AT THE 1-WEEK POST-OP VISIT. AT THE TWO- WEEK FOLLOW-UP VISIT, THE PATIENT NOTED THAT IT IS HARD TO TELL IF VISUAL ACUITY (VA) IN THE LEFT EYE HAS CHANGED DUE TO "STUFF" IN THE WAY OF HER VISUAL ACUITY. OCULAR MEDICATION (DROPS) WERE PRESCRIBED FOR THE LEFT EYE. VISUAL ACUITY VALUES WERE REPORTED AS FOLLOWS: SC (SANS CORRECTION) VA PRE-OP: 20/100, <J10, SC VA POST-OP: 20/150, <J10. REQUESTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION BUT TO DATE NO RESPONSE HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available; Visual Disturbances; Vitreous Floaters
MAUDE report 8805424 ↗InjuryFeb 13, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT HAD TO RETURN TO THE OPERATING ROOM FOR EXPLANT OF A ZXT375 23.5 DIOPTER INTRAOCULAR LENS (IOL) DUE TO INCORRECT LENS POWER. THE LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE AND REPLACED WITH A ZXT300 22.0 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY POST-OP. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6327749 ↗
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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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