TECNIS IOL ZKU150 (REF ZKU150U190)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC LOW ADD 1-PC 19.0D CYL1.5 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474687004), received between Sep 4, 2024 and Mar 25, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Blurred Vision1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE HAPTIC OF THE NON PRELOADED INTRAOCULAR LENS (IOL) BROKE OFF DURING INSERTION. THERE WAS PATIENT CONTACT. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21691468 ↗InjuryOct 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO WRONG POWER IOL. THERE WAS NO PATIENT INJURY SUCH AS CAPSULE TEAR. NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES PERFORMED. REPLACEMENT IOL WAS A NON-JOHNSON AND JOHNSON LENS. PATIENT OUTCOME WAS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20436725 ↗InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TWO PRELOADED INTRAOCULAR LENSES(IOL) WERE IMPLANTED AND EXPLANTED FROM THE LEFT EYE OF THE PATIENT. THE FIRST LENS (ZKU150U185, S/N (B)(6)) WAS IMPLANTED IN THE PATIENT'S EYE AND EXPLANTED DUE TO BLURRY VISION AND REPLACED WITH SAME MODEL AND DIOPTER LENS (S/N:(B)(6)) IN A SECONDARY PROCEDURE. THE PATIENT COMPLAINED OF BLURRY VISION WITH THE REPLACED SECOND LENS TOO. THE REPLACED SECOND LENS WAS EXPLANTED AND REPLACED WITH LENS FROM ANOTHER MANUFACTURER IN A SECONDARY PROCEDURE. THERE WERE NO PATIENT ISSUES. PLATINUM CARTRIDGE WAS USED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision
MAUDE report 20139211 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 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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