TECNIS IOL ZXT375 (REF ZXT375U255)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 25.5D 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474607088), received between Jul 24, 2019 and Jul 24, 2019 — classified as 1 injury.
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
Patient problems
- Blurred Vision1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZCT375 25.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. THE PATIENT IS EXPERIENCING BLURRY VISION SINCE SHE CANNOT READ CLOSE-UP. SHE FEELS THIS IS AFFECTING HER DAILY LIFE. CONSEQUENTLY, SHE WILL HAVE TO WEAR CONTACT LENSES. AT THE TIME OF THIS CALL NO ADDITIONAL PROCEDURES HAD BEEN PLANNED OR SCHEDULED. PER THE PATIENT, THE DOCTOR SUGGESTED SURGERY, BUT THE PATIENT IS NOT CONSIDERING ANY MORE SURGERIES. VIA FOLLOW-UP IT WAS LEARNED THAT THE DOCTOR PRESCRIBED CONTACT LENSES. HOWEVER, SHE HAS MORE ASTIGMATISM THAN THE DOCTOR EXPECTED AND THE CONTACT LENSES DID NOT HELP HER VISION. REPORTEDLY, THE DOCTOR SAID THEY WILL HAVE TO TRY TORIC HARD CONTACT LENSES TO FIX HER ASTIGMATISM. ADDITIONALLY, THE PATIENT REPORTED THAT HER DOCTOR ONLY TESTED HER PRE-SURGERY WITH CONTACT LENSES ON. SHE PROVIDED THE FOLLOWING PRE AND POST VISION OUTCOME. PRE-SURGERY VISION WITH CONTACTS: LEFT EYE: 20/50 +2, RIGHT EYE: 20/30 -2. POST-SURGERY LEFT EYE: L 21/50 +2 (WITHOUT CONTACTS) NOTE:PATIENT LIKELY MEANT 20/50, BUT HER VISION WAS BLURRY SO THE IOL WAS EXPLANTED. SECOND LENS INFORMATION FOR THE LEFT EYE, SECOND LENS FOR THE LEFT EYE ''SOON AFTER SURGERY'': LEFT: 20/50
Patient problems: Blurred Vision; No Code Available
MAUDE report 8820260 ↗
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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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