TECNIS IOL DIU450 (REF DIU450U085)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 08.5D 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 05050474748675), received between Sep 10, 2021 and Sep 10, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Unstable” (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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Unstable1
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.
InjurySep 10, 2021Unstable; Appropriate Device Problem Term/Code Not Available; Unstable; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN SECONDARY SURGICAL PROCEDURE DUE TO UNANTICIPATED, PATIENT INTOLERABLE REFRACTIVE ERROR, AND UNAIDED VISUAL ACUITY. THE PATIENT WAS SLIGHTLY HYPEROPIC AND HAD RESIDUAL ASTIGMATISM. ACCORDING TO THE DOCTOR, IT WAS PARTIALLY DUE TO BEING OFF AXIS/ROTATION OBSERVED DURING POST-OP EXAM BUT ALSO DUE TO THE JOHNSON AND JOHNSON TORIC CALCULATOR-RECOMMENDED MODEL BEING "TOO STRONG". SYMPTOMS WERE NOTED APPROXIMATELY SIX WEEKS POST-IMPLANT. PRE-OPERATIVE VISION: 20/30-2 BEST CORRECTED VISUAL ACUITY (BCVA); POST OPERATIVE VISION: 20/20-2 BCVA. A REPLACEMENT LENS MODEL DIU375, 9.0 DIOPTER WAS IMPLANTED. THERE WERE NO SURGICAL INTERVENTIONS; HOWEVER, THE DOCTOR INDICATED THAT SHE HAD A HARD TIME VISCO-COATING ONE OF THE HAPTICS FROM THE ORIGINAL DIU LENS IN ORDER TO MOBILIZE THE IOL OUT OF THE CAPSULAR BAG. THE DOCTOR THOUGHT THAT PERHAPS THE FROSTED HAPTIC EDGE MAY HAVE SOMETHING TO DO WITH IT. THE DOCTOR EXPLAINED THAT WHEN SHE ATTEMPTED HER USUAL TECHNIQUE - BISECT THE OPTIC ABOUT 75% AND CARTWHEEL THE LENS OUT THE ORIGINAL (2.2 MM) WOUND - THIS ALWAYS WORKS WELL WITH THE COMPETITOR¿S LENS. THIS IOL SEE
Patient problems: Visual Impairment
MAUDE report 12451800 ↗
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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