TECNIS IOL ZLU150 (REF ZLU150U250)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC LOW ADD 1-PC 25.0D 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474689466), received between Nov 16, 2021 and Aug 30, 2022 — classified as 2 injuries.
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 Problem2
Patient problems
- Blurred Vision1
- Halo1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BLURRY/FOGGY VISION AND DIFFICULTY WITH NEAR VISION IN THEIR LEFT EYE (OS) RESULTING IN THE NEED FOR AN EXPLANT OF THE INTRAOCULAR LENS (IOL). THE PATIENT'S PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY WAS 20/30 - 1 AND POST-OPERATIVE UNCORRECTED VISUAL ACUITY WAS 20/80. THE INTENDED TARGET WAS PLANO. THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL AND DIOPTER. THERE WAS NO REPORTED PATIENT INJURY. THE IOL WILL NOT BE RETURNED FOR INVESTIGATION AS IT WAS DISCARDED. AT ONE WEEK POST SURGERY THE PATIENT INDICATED THAT THEIR VISION IS IMPROVING BUT SOME DAYS THE VISION IS BLURRY/WORSE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision
MAUDE report 15325153 ↗InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO REFRACTIVE SURPRISE BECAUSE OF HALOS AND GLARES. ANOTHER JOHNSON & JOHNSON ZCU150 LENS (DIFFERENT MODEL AND SAME DIOPTER) WAS IMPLANTED AS A REPLACEMENT. PATIENT IS DOING GOOD POST-OPERATIVELY. NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES WERE REQUIRED. THERE WAS NO PATIENT INJURY. THE EXPLANTED IOL WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Halo; Visual Disturbances; Visual Impairment
MAUDE report 12820894 ↗
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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