TECNIS IOL ZXT150 (REF ZXT150U105)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 10.5D 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 05050474605015), received between May 24, 2017 and Feb 16, 2022 — 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
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2022Break; Break
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13546585 ↗InjuryMay 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A ZXT150 10.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT HAVING A MYOPIC OUTCOME BUT DID NOT EXPERIENCE ANY OTHER VISUAL ISSUES. THE LENS WAS REPLACED WITH THE SAME MODEL IOL WITH A LOWER DIOPTER. THERE WAS NO PATIENT INJURY OR CAPSULE TEAR REPORTED. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY REQUIRED. PATIENT IS DOING FINE WITH NO COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6586833 ↗
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- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens73 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens71 reports
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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