TECNIS IOL ZKU150 (REF ZKU150U105)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC LOW ADD 1-PC 10.5D CYL1.5 · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474686830), received between Jun 25, 2020 and Jun 25, 2020 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Inflammation1
- No Code Available1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AT ONE DAY POST IMPLANT OF AN INTRAOCULAR LENS, THE PATIENT EXPERIENCED POSSIBLE TOXIC ANTERIOR SEGMENT SYNDROME (TASS). ADDITIONAL INFORMATION STATES SURGEON NOTED DECREASED VISUAL ACUITY (VA) 1-DAY POSTOP, AND PERFORMED AN ANTERIOR CHAMBER (AC) TAP, RESULTS SHOWED NO GROWTH; HOWEVER, PATIENT STILL COULD NOT SEE, COUNTING FINGERS. THE SURGEON INITIALLY TRIED TO PERFORM A VITREOUS TAP, BUT NOTHING WOULD COME OUT, USED G25 NEEDLE SO HE PERFORMED AN AC TAP INSTEAD. SURGEON COULD NOT SEE THE FUNDUS AT THIS TIME, NO RED REFLEX. ONE WEEK LATER, HE NOTED AC CLEARING UP AND CAN NOW SEE THE RETINA. PATIENT IS POST RETINAL DETACHMENT WITH SCLERAL BUCKLE A FEW MONTHS PRIOR TO CATARACT SURGERY. PATIENT WAS PRESCRIBED MEDICATION AT ONE-DAY POST-OP BUT IS CURRENTLY BEING TAPERED OFF THE MEDICATION. THE ISSUE HAD SIGNIFICANTLY AFFECTED THE PATIENT ABILITY TO PERFORM ACTIVITIES OF DAILY LIFE BUT IS IMPROVING. TO DATE THE LENS REMAINS IMPLANTED AND THE PATIENT IS GETTING BETTER. THE SURGEON NOTED HE HAD 10 CASES AT THE SAME FACILITY THE SAME DAY AND USED THE SAME OPHTHALMIC VISCOSURGICAL DEVICE (OVD), IRRIGATION SOLUTION, ANESTHETIC, AND POST-OP DROPS, WITH NO OTHER EPISODES O
Patient problems: Inflammation; No Code Available; Visual Impairment
MAUDE report 10193409 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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