TECNIS IOL ZXT225 (REF ZXT225U130)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 13.0D CYL2.25 · 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 05050474605657), received between Jan 30, 2020 and Oct 1, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Unintended Movement1
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 1, 2020Unintended Movement; Unintended Movement
A DOCTOR REPORTED OF A PATIENT WITH BILATERAL ROTATION. REPORTEDLY THE PATIENT HAD HIGH MYOPIA AND REQUIRED CAPSULAR TENSION RINGS (CTRS) AT THE TIME OF SURGERY TO STABILIZE THE CAPSULAR BAG. THE PATIENT IS COMPLAINING OF POOR VISION AND GLARE. THE DOCTOR ROTATED THE LENS TO ITS IDEAL AXIS IN A SECOND PROCEDURE. SUTURES WERE USED DURING THE PROCEDURE AND THE LENS REMAINS IMPLANTED. NO HARM OR INJURY POST-OP WAS NOTED IN THE RECORD. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT IS FOR THE PATIENT'S RIGHT EYE (OD). A SEPARATE REPORT WILL BE FILED FOR THE PATIENT'S LEFT EYE (OS).
Patient problems: No Code Available; Visual Impairment
MAUDE report 10618066 ↗MalfunctionJan 30, 2020Break; Break
THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS. THE EVENT WAS RELATED TO LENS DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9648597 ↗
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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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