TECNIS IOL ZXT375 (REF ZXT375U130)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 13.0D 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 05050474606838), received between Jan 25, 2021 and Jul 13, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Unstable” (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
- Unstable1
Patient problems
- Blurred Vision1
- Discomfort1
- Flashers1
- Halo1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 13, 2021Adverse 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 LEFT EYE DUE TO PATIENT NOT SATISFIED WITH IT BECAUSE THE VISION GOT WORSE AFTER SURGERY. EXPLANTED LENS WAS REPLACED WITH THE SAME MODEL BUT HIGHER DIOPTER POWER JOHNSON AND JOHNSON IOL. IT WAS NOTED THAT THE ISSUE WAS DISCOVERED DURING POST-OP EXAMINATION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Discomfort
MAUDE report 12162903 ↗InjuryJan 25, 2021Unstable; Unstable
DURING AN UNMASKED CLINICAL RESEARCH STUDY EVALUATION OF A PATIENT WHO WAS BILATERALLY IMPLANTED, THE SITE NOTED AN AXIS MISALIGNMENT OF THE INTRAOCULAR LENS (IOL) IN THE LEFT EYE OF A PATIENT ON (B)(6) 2020. THE PRE-OPERATIVE BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) OF LEFT EYE (OS) WAS 20/20. THE IOL AXIS PLACEMENT WAS AT 162 DEGREES AT THE TIME OF SURGERY. AT THE 1-WEEK VISIT ON (B)(6) 2020, THE UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) WAS 20/60 AND BCDVA WAS 20/20. THE IOL HAD ROTATED 38 DEGREES. THE PATIENT REPORTED THE FOLLOWING SYMPTOMS ON (B)(6) 2021: NON-DIRECTED OCULAR/VISUAL SYMPTOM COMPLAINTS FOR THE LEFT EYE- BLURRED VISION/DIFFICULTY WITH VISION DISTANCE AND NEAR AND GHOSTING. COMPLAINTS BASED ON THE QUESTIONNAIRE FOR BOTH EYES- MODERATELY BOTHERED BY HALOS- READING SMALL PRINT; MODERATELY BOTHERED BY STARBURSTS- READING SIGNS; MODERATELY BOTHERED BY DOUBLE VISION- READING SMALL PRINT; MODERATELY BOTHERED BY SENSITIVITY TO LIGHT- READING; MODERATELY BOTHERED BY GLARE- READING; MODERATELY BOTHERED BY POOR LOW LIGHT VISION READING. IT WAS INDICATED THAT THE IOL REPOSITIONING WAS COMPLETED SUCCESSFULLY WITH NO PATIENT INJURY ON (B)(6) 2021 AS IT HAD BEEN SCHEDULED
Patient problems: Blurred Vision; Flashers; Halo; Visual Disturbances; Visual Impairment
MAUDE report 11228268 ↗
Other Extended depth of focus intraocular lens devices
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens101 reports
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- 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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