TECNIS IOL DIU375 (REF DIU375U050)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 05.0D CYL3.75 · Class 3 · Implant
Data updated Oct 13, 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 05050474748019), received between Jun 14, 2021 and Nov 4, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Scratched Material2
- Ejection Problem1
- Material Opacification1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2024Material Opacification; Material Opacification
DURING PRODUCT HANDLING THE PRE-LOADED DIU375 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED TO HAVE LOOKED HAZY AND IT HAD A SPOT ON IT. THERE WAS NO PATIENT CONTACT WITH THE IOL. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20595830 ↗MalfunctionApr 4, 2024Use of Device Problem; Scratched Material; Ejection Problem; Use of Device Problem; Scratched Material; Ejection Problem
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) PRELOADED INTRAOCULAR LENS (IOL) DIDN¿T IMPLANT ALL THE WAY THROUGH THE INCISION. THE SURGEON REMOVED THE LENS FROM SUB-INCISIONAL AND THE TECHNICIAN RELOADED IT INTO A NEW CARTRIDGE AND INSERTER. CUSTOMER IS UNSURE IF THE SCRATCH WAS ON THE LENS PRIOR TO SURGERY OR IF IT HAPPENED WHEN MANIPULATING THE LENS OUT OF THE EYE AND INTO A NEW CARTRIDGE. CUSTOMER OPENED A NEW IOL JNJ MODEL DIU300 AND THE LENS WAS INSERTED AS PLANNED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19047873 ↗InjuryJun 14, 2021Scratched Material; Scratched Material
IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS SCRATCHED. THE EVENT WAS OBSERVED UPON INSERTION INTO THE PATIENT'S LEFT EYE AND THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER. THERE WAS NO INJURY REPORTED, HOWEVER, SUTURE WAS PLACED. THE PATIENT WAS DOING GOOD. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11996758 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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