TECNIS IOL ZLU225 (REF ZLU225U185)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC LOW ADD 1-PC 18.5D CYL2.25 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474689923), received between Aug 7, 2023 and Aug 7, 2023 — classified as 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
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2023Break; Break
IT WAS REPORTED THE ZLU225 MODEL INTRAOCULAR LENS (IOL) FRONT HAPTIC WAS INCORRECTLY POSITIONED AS THE SURGEON STARTED TO PLACE THE LENS. THE SURGEON STOPPED AND PULLED AWAY FROM THE PATIENT, LENS WAS STILL IN CARTRIDGE, AND THERE WAS PATIENT CONTACT. IT WAS NOTED THE CARTRIDGE WAS SPLIT AND LEADING HAPTIC HAD GONE THROUGH THE CARTRIDGE. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE 1MTEC30 CARTRIDGE TIP WAS CRACKED AND THE HAPTIC WAS ALSO DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER IOL SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT CAPTURED THE HAPTIC DAMAGE ISSUE. A SEPARATE REPORT CAPTURES THE CARTRIDGE TIP DAMAGE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17477292 ↗
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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