TECNIS IOL DIU300 (REF DIU300U140)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 14.0D 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 05050474747609), received between Sep 28, 2021 and Apr 25, 2024 — classified as 2 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
- Break1
- Delivered as Unsterile Product1
- Manufacturing, Packaging or Shipping 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 25, 2024Break; Break
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD A TRAILING HAPTIC WHICH WAS ALMOST COMPLETELY CUTOFF. THE IOL WAS FULLY INSERTED INTO THE PATIENT¿S RIGHT EYE. THE IOL WAS THEN REMOVED. A BACKUP LENS OF THE SAME MODEL AND DIOPTER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT INJURIES SUCH AS CAPSULE TEAR, INCISION ENLARGEMENT OR VITRECTOMY. NO PRESCRIBED MEDICATIONS TO PREVENT PERMANENT IMPAIRMENT. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19178092 ↗MalfunctionSep 28, 2021Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT TWO PRELOADED INTRAOCULAR LENSES (IOLS) WERE STERILE COMPROMISED AS THE PACKAGING WAS NOT FULLY INTACT. ONE OF THE LENS PACKAGE HAD A LITTLE HOLE BY THE KNOB AND THE OTHER WAS COMPLETELY RIPPED AT THE FOLD BY THE KNOB. THE DEVICES WERE NOT DAMAGED. HOWEVER, ONE BOX LOOKED LIKE IT MIGHT HAVE BEEN DAMAGED DURING SHIPPING, BUT THE SERIAL NUMBER OF THE BOX COULD NOT BE CONFIRMED. THERE WAS NO PATIENT CONTACT WITH THE LENSES. THROUGH FOLLOW-UP, IT WAS CLARIFIED THAT THE STERILE POUCH WAS DAMAGED ON BOTH IOLS. THE BOX WAS DAMAGED ON JUST ONE OF THE LENS. NO FURTHER INFORMATION WAS AVAILABLE. THIS REPORT CAPTURES ONE OF THE LENS AND A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12545007 ↗
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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