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TECNIS IOL ZXT375 (REF ZXT375U150)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 15.0D 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 05050474606876), received between Jun 5, 2018 and Jun 22, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (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
  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 22, 2021Mechanical Problem; Mechanical Problem

    IT WAS REPORTED THAT A (B)(4) MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO MECHANICAL COMPLICATIONS OF THE LENS. NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE PERFORMED. THE REPLACEMENT LENS USED IS A DIFFERENT MODEL AND DIOPTER LENS. NO FURTHER INFORMATION AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12046898 ↗
  • InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A ZXT375 15.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT''S RIGHT EYE (OD) ON (B)(6) 2018. REPORTEDLY, THE PRE-OPERATIVE SYMFONY TORIC CALCULATOR RECOMMENDED A MODEL OF ZXT375 LEAVING RESIDUAL CYLINDER +0.94 AXIS 83. ALSO, AK X 90 WAS PERFORMED FOR PREDICTED RESIDUAL CYLINDER. INTRA-OPERATIVE OCULAR RESPONSE ANALYZER (ORA) RECOMMENDED 15.0 DIOPTER. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT HAD RESIDUAL ASTIGMATISM AND A FLIPPED AXIS NOTED AT THEIR OFFICE VISIT WITH THE DOCTOR ON (B)(6) 2018. A PRE-OPERATIVE MEASUREMENT WAS DONE AGAIN USING THE SYMFONY TORIC CALCULATOR, WHICH RECOMMENDED ZXT300 WITH PREDICTED RESIDUAL CYLINDER +0.03 AXIS 61. INTRA-OPERATIVE OCULAR RESPONSE ANALYZER (ORA) MEASUREMENTS AFTER REMOVAL OF ORIGINAL LENS RECOMMENDED 15.5 DIOPTER, BUT STILL RECOMMENDED ZXT375. HOWEVER, THE DOCTOR CHOSE A ZXT300 15.5 DIOPTER LENS AS THE REPLACEMENT LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 7568167 ↗

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Sources and updates

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