TECNIS IOL DIU450 (REF DIU450U175)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 17.5D CYL4.50 · 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 05050474748859), received between Feb 27, 2026 and Feb 27, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (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.
Reports received per month
Most reported problems
Device problems
- Application Program Problem: Dose Calculation Error1
Patient problems
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 27, 2026Application Program Problem: Dose Calculation Error
IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIU450, IN THE PATIENT¿S LEFT EYE, THE PATIENT EXPERIENCED A REFRACTIVE ERROR DUE TO THE SELECTION OF AN INCORRECT LENS POWER. THE IMPLANTED IOL WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A LENS OF A DIFFERENT CYLINDER AND DIOPTER TO IMPROVE THE VISUAL OUTCOME. NO PATIENT HARM WAS REPORTED. THE COMPLAINT DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 24471546 ↗
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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