TECNIS IOL ZCU150 (REF ZCU150U200)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 20.0D 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 05050474657793), received between Dec 30, 2019 and May 29, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Eye Injury1
- No Code Available1
- Vitrectomy1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PRELOADED LENS WAS EXPLANTED DUE TO UNKNOWN REASON. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Eye Injury
MAUDE report 22106287 ↗InjuryDec 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
WAS REPORTED THAT A ZXR00 20.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO MYOPIA. THE PATIENT IS NOT BOTHERED BY ANY DYSPHOTOPSIA AND LOVES HER FIRST EYE SURGERY WITH A THE SYMFONY LENS, BUT THE EYE TURNED OUT PLANO SO THE DOCTOR ATTEMPTED TO IMPROVE HER NEAR VISION BY IMPLANTING A PIGGY BACK LENS. THIS RESULTED IN THE PATIENT BEING TOO MYOPIC. THEREFORE, THE DOCTOR DECIDED TO EXPLANT THE IOL AND REPLACED IT WITH THE SAME MODEL BUT A LOWER DIOPTER 19.0. A VITRECTOMY WAS REQUIRED. THRU FOLLOW-UP THE CUSTOMER ALSO EXPLAINED THAT THE PATIENT¿S CAPSULE DID NOT TEAR, PATIENT HAD A 1-2 CLOCK HOUR ZONLUAR DIALYSIS WITH A FEW VITREOUS STRANDS ENTERING THE ANTERIOR CHAMBER THAT REQUIRED A LIMITED ANTERIOR VITRECTOMY. THE LENS WAS PERFECTLY STABLE AND ON AXIS. FURTHER FOLLOW-UP WAS CONDUCTED BUT THE CUSTOMER DID NOT HAVE ANY MORE INFORMATION REGARDING THIS ISSUE. REPORTEDLY, THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available; Vitrectomy
MAUDE report 9532341 ↗
Other LENS, INTRAOCULAR, TORIC OPTICS devices
- TECNIS IOL ZCT150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS1 recall7 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS43 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS36 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS32 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS30 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS29 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS21 reports
- TECNIS IOL DIU150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS19 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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