TECNIS IOL ZXT300 (REF ZXT300U085)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 08.5D CYL3.00 · 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 05050474606159), received between Aug 2, 2019 and Jan 21, 2020 — classified as 2 injuries.
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
Patient problems
- No Code Available2
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FEMALE PATIENT WAS IMPLANTED WITH A ZXT300 INTRAOCULAR LENS (IOL) AND EXPERIENCED A POST-OP SURPRISE. IT WAS LEARNED LATER THAT THE ZXT300, 8.5 DIOPTER IOL WAS EXPLANTED. THE LENS WAS REPLACED WITH ANOTHER ZXT300, BUT LOWER DIOPTER 10.0. THE EXPLANTED IOL WAS DISCARDED BY THE FACILITY. AT EXCHANGE THERE WAS NO PATIENT POST-OP INJURY, NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 9612747 ↗InjuryAug 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT300 +8.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING UNEXPECTED POST OP REFRACTION, DISTORTION AT DISTANCE AND NEAR AND ASTIGMATISM CORRECTION. THE PATIENT HAD OVER-CORRECTION OF CYLINDER WITH THE LENS IN THE CORRECT POSITION, PATIENT NEEDS NON TORIC. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. PATIENT OUTCOME REPORTED AS RECOVERED WITH NEW IMPLANT. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Code Available; Visual Disturbances
MAUDE report 8853989 ↗
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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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