TECNIS IOL DIU375 (REF DIU375U200)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 20.0D CYL3.75 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474748316), received between Feb 27, 2023 and Apr 15, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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
- Crack1
- Ejection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 15, 2026Ejection Problem
THE TRAILING HAPTIC OF THE DIU375 MODEL INTRAOCULAR LENS (IOL) WAS STUCK IN THE INSERTER, REQUIRING THE USE OF FORCEPS FOR REMOVAL. THERE WAS NO PATIENT HARM. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885885 ↗MalfunctionFeb 27, 2023Crack; Crack
IT WAS REPORTED THE TIP OF PRE-LOADED DIU375 CARTRIDGE WAS DAMAGED/CRACKED AND DELIVERED LENS THROUGH ANOTHER CARTRIDGE. THERE WAS PATIENT CONTACT WITH THE DEVICE HOWEVER THERE WAS NO PATIENT ISSUES. THE DIU375 IOL IS NOT AVAILABLE FOR RETURN AS IT WAS IMPLANTED INTO THE PATIENT'S OPERATIVE EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16448426 ↗
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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