TECNIS IOL DIU225 (REF DIU225U150)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 15.0D CYL2.25 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474747036), received between Feb 15, 2023 and Oct 2, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Device Damaged Prior to Use2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 2, 2023Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) INTERIOR OF THE IOL BOXES MAY HAVE BEEN OK, BUT THE IOL AND SHIPPING BOXES WERE DAMAGED AND THE CUSTOMER DIDN'T TRUST THE INTEGRITY OF THE PRODUCT. THE OCCURRENCE THAT OCCURRED DURING THE RECEIPT OF THE PRODUCT. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17857253 ↗MalfunctionOct 2, 2023Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) INTERIOR OF THE IOL BOXES MAY HAVE BEEN OK, BUT THE IOL AND SHIPPING BOXES WERE DAMAGED AND THE CUSTOMER DIDN'T TRUST THE INTEGRITY OF THE PRODUCT. THE OCCURRENCE THAT OCCURRED DURING THE RECEIPT OF THE PRODUCT. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17857245 ↗InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO A REFRACTIVE ERROR. THE PATIENT'S VISION WAS NOT CLEAR. THERE WAS NO REPORT OF A VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES BEING REQUIRED. THE DEVICE HAS BEEN DISCARDED AND NOT AVAILABLE FOR RETURN. ANOTHER JOHNSON & JOHNSON LENS, MODEL DIU150 14.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 16383531 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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