TECNIS IOL DIU300 (REF DIU300U170)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 17.0D 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
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474747661), received between Feb 10, 2022 and Nov 10, 2025 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Break” (4 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.
Reports received per month
Most reported problems
Device problems
- Break4
- Adverse Event Without Identified Device or Use Problem1
- Application Program Problem: Dose Calculation Error1
- Crack1
- Failure to Advance1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Visual Impairment1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS FOUND TO HAVE A TIP THAT WAS NOT BEVELED AND APPEARED TO HAVE BEEN MANUFACTURED INCORRECTLY. ADDITIONALLY, THE LENS WAS DESCRIBED AS BENT AND INCORRECT. THE ISSUE WAS IDENTIFIED DURING HANDLING PRIOR TO INSERTION. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23516604 ↗InjuryNov 27, 2024Application Program Problem: Dose Calculation Error; Adverse Event Without Identified Device or Use Problem; Application Program Problem: Dose Calculation Error; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A DOCTOR HAD TO EXCHANGE A MONOFOCAL TORIC INTRAOCULAR LENS (IOL) FOR A DIFFERENT POWER DUE TO A REFRACTIVE SURPRISE. THE REPLACEMENT LENS WAS REPLACED WAS OF THE SAME MODEL AND CYLINDER BUT OF A HIGHER DIOPTER (19.5D). THERE WERE NO SURGICAL COMPLICATIONS AND ORIGINAL LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 20800359 ↗MalfunctionDec 22, 2023Scratched Material; Scratched Material
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS SCRATCHED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18383776 ↗MalfunctionFeb 17, 2023Break; Failure to Advance; Break; Failure to Advance
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FAULTY, WILL NOT DEPLOY. THERE WAS NO PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16400915 ↗MalfunctionFeb 10, 2022Break; Break
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DAMAGED UPON OPENING PRIOR TO PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13509973 ↗MalfunctionFeb 10, 2022Break; Break
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DAMAGED UPON OPENING PRIOR TO PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13509895 ↗
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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