TECNIS IOL ZKU150 (REF ZKU150U305)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC LOW ADD 1-PC 30.5D 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
- 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 05050474687233), received between Aug 12, 2020 and Aug 12, 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. 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 Problem1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2020Adverse 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 FROM A PATIENT¿S LEFT EYE (OS) DUE TO THE WRONG LENS POWER. THE SURGEON IMPLANTED A 30.5 DIOPTER AND DURING THE POST OPERATIONAL VISIT IT WAS DETERMINED THAT A DIFFERENT DIOPTER LENS IS NEEDED. A REPLACEMENT LENS OF A DIFFERENT MODEL (ZKU225) AND DIOPTER (28.0) WAS USED. IT WAS REPORTED THAT THE INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT IS FOR THE PATIENT¿S LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PATIENT¿S RIGHT EYE.
Patient problems: No Code Available
MAUDE report 10394586 ↗
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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