TECNIS IOL DIU600 (REF DIU600U240)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 24.0D CYL6.00 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474750166), received between Dec 12, 2023 and Dec 12, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Application Program Problem: Dose Calculation Error1
Patient problems
- Blurred Vision1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2023Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
IT WAS REPORTED THAT THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE IN A SECONDARY PROCEDURE DUE TO A MEASUREMENT MALFUNCTION AND THE PATIENT COULD NOT SEE CLEARLY. THE ISSUE WAS FIRST NOTED WITHIN THE FIRST TWO WEEKS AFTER SURGERY. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIB00, 22.0 DIOPTER). THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT OUTCOME IS GOOD. THE DEVICE WAS DISCARDED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT HAD A PRE-OPERATIVE ASTIGMATISM THAT WARRANTED THE ORIGINAL TORIC IOL CORRECTION, WHICH MEASURED FIVE DIOPTER OF CYLINDER ON IOL MASTER. THE SURGEON PERFORMED ADVANCED SURFACE TREATMENT (AST) OVER THE ORIGINAL IOL AS FIRST ATTEMPT TO IMPROVE THE PATIENT¿S VISION, HOWEVER IT DID NOT MAKE ANY DIFFERENCE. THIS WAS HOWEVER LIKELY THE REASON FOR DIB00 SELECTION FOR IOL EXCHANGE. THE PATIENT REPORTED IMPROVEMENT OF VISION AFTER THE IOL EXCHANGE. THE PATIENT IS APPROACHING TWO WEEKS INTO THE POST OPERATIVE PERIOD AND THE VISION WILL BE CHECKED AGAIN ON (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision
MAUDE report 18315089 ↗
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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