TECNIS IOL ZXT375 (REF ZXT375U140)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 14.0D CYL3.75 · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474606852), received between Feb 6, 2017 and Jun 2, 2018 — classified as 3 injuries.
The most frequently reported specific device problem is “Unintended Movement” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Unintended Movement2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZXT375 14.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE OF GLARE ISSUES AND WAS REPLACED WITH A ZCT300 MODEL LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 7563641 ↗InjuryOct 16, 2017Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A ZXT375 14.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017 . IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO SUBLUXATION OF THE IOL WITH ANISOMETROPIA. ALSO, THE DOCTOR STATED THE ANISOMETROPIA INTERFERED WITH THE PATIENT'S REGULAR ACTIVITIES AND THE VISION WAS 20/70 POST-OPERATIVELY. THERE WAS AN INCISION ENLARGEMENT, BUT NO VITRECTOMY OR SUTURES USED. THE LENS WAS REPLACED WITH A NON-AMO LENS. REPORTEDLY, THERE WAS NO POST-OPERATIVE PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6953494 ↗InjuryFeb 6, 2017Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD ROTATED 30 DEGREES. THE LENS WAS THEN EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6306125 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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