TECNIS IOL ZCU150 (REF ZCU150U110)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 11.0D CYL1.50 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474657618), received between May 26, 2021 and Jan 12, 2024 — classified as 2 malfunctions.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Ejection Problem1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2024Material Split, Cut or Torn; Ejection Problem; Material Split, Cut or Torn; Ejection Problem
IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS(IOL) CARTRIDGE DID NOT COME DOWN PROPERLY AND TORE THE LENS. ADDITIONAL INFORMATION INDICATED THAT THE LENS WAS NOT IN CONTACT WITH THE EYE ONLY THE CARTRIDGE TIP MAKE CONTACT WITH THE EYE. THE REASON FOR THE ISSUE WAS LOADING ERROR. THE PROCEDURE WAS COMPLETED WITH THE BACK UP LENS. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18505772 ↗MalfunctionMay 26, 2021Break; Break
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE RIGHT EYE AND REMOVED DURING THE SAME PROCEDURE DUE TO A BENT/BROKEN HAPTIC. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11888377 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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