TECNIS IOL DIU600 (REF DIU600U180)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 18.0D CYL6.00 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474750043), received between Sep 13, 2023 and Sep 13, 2023 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Break1
- Ejection Problem1
- Failure to Fold1
- Operating System Becomes Nonfunctional1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2023Break; Failure to Fold; Operating System Becomes Nonfunctional; Ejection Problem; Break; Failure to Fold; Operating System Becomes Nonfunctional; Ejection Problem
IT WAS INITIALLY REPORTED THAT THE CUSTOMER EXPERIENCED A FAULTY INTRAOCULAR LENS (IOL) WHILE PERFORMING SURGERY. THE DOCTOR WAS ATTEMPTING TO DELIVER/INSERT THE LENS UNTIL IT WAS NOTICED THAT THE LENS WAS NOT FOLDED PROPERLY AND WAS COMING OUT WRONG DUE TO A BENT PLUNGER ROD. THERE WAS PATIENT CONTACT, BUT NO INJURY REPORTED. THE IOL WAS DISPOSED OF, AND A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER IMPLANTED IN THE PATIENT¿S LEFT EYE. IT WAS CONFIRMED THAT THE LENS WAS NOT STUCK IN THE CARTRIDGE. ADDITIONAL INFORMATION PROVIDED INDICATED THAT THE HAPTIC WAS DAMAGED. THE LENS WAS PARTIALLY DELIVERED, AND ADDITIONAL SURGICAL MANEUVERS WERE PERFORMED, BUT NO UNPLANNED SURGICAL INTERVENTIONS, SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE REQUIRED. THE PATIENT OUTCOME WAS NOT PROVIDED. IT WAS NOTED THAT THE BALANCED SALT SOLUTION (BSS) THAT WAS USED WAS ROOM TEMPERATURE AND BOTH BSS AND BSS PLUS WERE ADDED INTRAOCULARLY. THE BSS INTRODUCED INTO THE CARTRIDGE, FROM BOTH THE TIP AND FROM THE CARTRIDGE CANOPY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17741772 ↗
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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