TECNIS IOL DIU300 (REF DIU300U075)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 07.5D CYL3.00 · 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 05050474747470), received between Aug 23, 2022 and Aug 23, 2022 — 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
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S VISION DID NOT IMPROVE AND WAS STILL BLURRY FOLLOWING SURGERY ON THEIR LEFT EYE (OS) RESULTING IN THE NEED TO EXPLANT THE INTRAOCULAR LENS (IOL). THE INTENDED/TARGETED POST-OPERATIVE REFRACTION WAS PLANO AND INTENDED REFRACTIVE FOCAL POINT WAS DISTANCE VISION. THE PATIENT'S PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/40. THE PATIENT'S POST-OPERATIVE UNCORRECTED VISUAL ACUITY (UCVA) WAS 20/40 AND BCVA 20/20. IT WAS STATED THAT THE PATIENT HAD AN OLD CORNEAL SCAR THAT INTERFERED WITH THE OPTICAL BIOMETRY MEASUREMENTS. DUE TO THIS THE PATIENT WAS SENT FOR A PENTACAM TO CONFIRM THE KERATOMETRY READINGS. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS STATED TO BE DOING WELL FOLLOWING THE EXPLANT DURING WHICH A DIFFERENT MODEL LENS OF HIGHER DIOPTER POWER WAS IMPLANTED (TECNIS TORIC LL LENS MODEL ZCU150, +9.0 DIOPTER) CURRENT UCVA PROVIDED AS 20/20. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 15280201 ↗
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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