TECNIS IOL DIU450 (REF DIU450U215)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 21.5D 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474748934), received between Nov 27, 2023 and Jun 10, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Ejection Problem1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Blurred Vision1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIU450, WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. POST-OPERATIVELY, THE PATIENT EXPERIENCED BLURRED VISION AND WAS UNABLE TO ADAPT TO THE TORIC LENS. THE LENS WAS SUBSEQUENTLY EXCHANGED FOR A DIFFERENT MODEL (DCB00, 21.5 D). THE COMPLAINT DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision
MAUDE report 25456480 ↗MalfunctionMar 25, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A TRAILING HAPTIC THAT SPLIT IN HALF AS IT WAS INSERTED INTO THE PATIENT'S EYE. THE LENS WAS REMOVED MANUALLY AND ANOTHER LENS WAS INSERTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21690260 ↗MalfunctionMar 6, 2025Ejection Problem; Ejection Problem
DURING IMPLANTATION THE DIU450 MODEL INTRAOCULAR LENS (IOL) WAS PREMATURELY DEPLOYED WITHIN CORNEAL TUNNEL INCISION. THERE WAS NO PATIENT INJURY DURING THE PROCEDURE. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21543178 ↗MalfunctionNov 27, 2023Break; Break
IT WAS REPORTED THAT THE TECNIS SIMPLICITY INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED FROM THE PATIENT'S LEFT EYE DURING SAME PROCEDURE DUE TO ONE HAPTIC WAS FOUND TO BE BROKEN AT THE HAPTIC-OPTIC JUNCTION AFTER THE IMPLANTATION OF THE IOL. REPORTEDLY APPEARING CONSISTENT WITH A MANUFACTURING DEFECT ( THE HAPTIC WAS SPLIT RIGHT AT THE DEMARCATION LINE WHERE IT WAS THE LEADING HAPTIC, AND THERE WAS NO CONTACT WITH THE INJECTION PLUNGER). THERE WAS NO INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY NEEDED. THE LENS WAS REPLACED WITH ANOTHER LENS WITH SAME MODEL, BUT WITH UNKNOWN DIOPTER. THE PATIENT'S POST-PROCEDURE STATUS IS FINE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18212893 ↗
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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