TECNIS IOL DIU300 (REF DIU300U155)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 15.5D CYL3.00 · 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 05050474747630), received between Apr 22, 2022 and Feb 22, 2023 — classified as 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 16, 2026.
Most reported problems
Device problems
- Break2
- Failure to Fold1
- Mechanical 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.
MalfunctionFeb 22, 2023Break; Failure to Fold; Mechanical Problem; Break; Failure to Fold; Mechanical Problem
IT WAS REPORTED THAT THERE WAS FOLDING ISSUE WITH AN INTRAOCULAR LENS (IOL) FOR A PATIENT'S LEFT EYE AND THE HAPTIC WAS BENT/BROKEN. INJECTOR WENT OVER, CUT TRAILING HAPTIC. THE ISSUE WAS NOTICED DURING HANDLING PRIOR TO INSERTION AND THERE WAS NO PATIENT CONTACT WITH THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF THE SAME MODEL AND DIOPTER AS THE REPLACEMENT FOR THE PATIENT¿S LEFT EYE. THE PRODUCT WILL NOT BE RETURNED AS IT WAS DISCARDED. NO FURTHER INFORMATION WILL BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16423900 ↗MalfunctionApr 22, 2022Break; Break
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS PUT IN PATIENT'S EYE THEN IT WAS NOTED THAT THE HAPTIC CRACKED. IOL HAD TO BE REMOVED AND ANOTHER WAS PLACED IN EYE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14187884 ↗
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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