TECNIS IOL DIU225 (REF DIU225U145)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 14.5D CYL2.25 · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474747029), received between Dec 13, 2023 and Jun 18, 2024 — classified as 1 injury, 1 malfunction.
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
- Device Dislodged or Dislocated1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE DIU225 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF LENS MALPOSITION. THE EXPLANTED IOL WAS REPLACED WITH THE SAME MODEL LENS BUT WITH A DIFFERENT DIOPTER, DIU225 13.0 DIOPTER IOL. THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION. PATIENT STATUS POST-LENS EXCHANGE WAS REPORTED AS FINE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19564151 ↗MalfunctionDec 13, 2023Crack; Crack
IT WAS REPORTED WHILE IMPLANTING THE PRE-LOADED DIU225 MODEL INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE, A SMALL PLASTIC SHARP BARB ON EACH LATERAL EDGE OF THE CARTRIDGE WAS OBSERVED. INSERTION OF THE IOL WENT FINE AND THE CASE CONCLUDED UNEVENTFULLY. THERE WAS NO PATIENT ISSUES AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. PATIENT STATUS POST-PROCEDURE IS UNKNOWN. DOCTOR IS CONCERNED HAVING SHARP EDGES THAT MAY COME INTO CONTACT WITH THE CAPSULE OR CATCH IN THE EDGE OF THE INCISION. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18323499 ↗
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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