TECNIS IOL ZXT150 (REF ZXT150U135)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 13.5D CYL1.50 · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474605077), received between Sep 24, 2019 and Nov 13, 2019 — classified as 1 injury, 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem1
- Unintended Movement1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2019Unintended Movement; Unintended Movement
IN A CLINICAL STUDY POST-OP EVALUATION, THE SITE NOTED AN AXIS MISALIGNMENT OF THE INTRAOCULAR LENS (IOL), MODEL ZXT150 13.5 DIOPTER. THE LENS HAD A ROTATION OF 148 DEGREES. ON (B)(6) 2019, IOL AXIS PLACEMENT OF THE LEFT EYE (OS) WAS 180 DEGREES. ON (B)(6) 2019, ONE (1) WEEK VISIT, IOL AXIS (OS) WAS 32 DEGREES. THERE IS NO SECONDARY SURGICAL INTERVENTION IS PLANNED AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS EMDR REPORT IS FOR THE PATIENT'S LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE PATIENT'S RIGHT EYE (OD).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9313795 ↗InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WAS IMPLANTED A ZXT150 INTRAOCULAR LENS (IOL). BUT THE PATIENT IS NOT HAPPY WITH IT. HENCE, AN EXPLANT IS PLANNED TO OCCUR. SEVERAL FOLLOW-UPS WERE DONE TO TRY TO ASK FOR CLARIFICATION AND ALSO OBTAIN INFORMATION BUT THERE WAS NO RESPONSE RECEIVED.
Patient problems: No Code Available
MAUDE report 9108775 ↗
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- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens73 reports
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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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