TECNIS IOL ZXT375 (REF ZXT375U080)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 08.0D 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474606739), received between Sep 27, 2019 and Sep 27, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Unintended Movement” (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
- Unintended Movement1
Patient problems
- Blurred Vision1
- No Code Available1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2019Unintended Movement; Unintended Movement
IT WAS REPORTED IN A CLINICAL STUDY THAT A ZXT375 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN A PATIENT. THE SITE NOTED AN AXIS MISALIGNMENT OF 24 DEGREES (LENS WAS PLACED AT 129) AND IT WAS NOTED AT 153 DURING THIS 1 WEEK POST-OP VISIT ON (B)(6) 2019. FOLLOW-UP CONFIRMED THE PATIENT'S VISUAL ISSUES WERE OF BLURRED VISION OVERALL. LENS REPOSITIONING OCCURRED THE SAME DAY ON (B)(6) 2019. THE LENS REMAINED IMPLANTED. VISION IMPROVED, UNCORRECTED VISUAL ACUITY (UCVA) 20/30, BEST CORRECTED VISUAL ACUITY (BCVA) 20/25. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; No Code Available; Visual Disturbances
MAUDE report 9131116 ↗
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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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