TECNIS IOL DIU150 (REF DIU150U160)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 16.0D CYL1.50 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474746466), received between Sep 16, 2021 and Nov 13, 2024 — classified as 3 injuries, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Break1
- Inaccurate Delivery1
Patient problems
- Eye Injury2
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED WITH THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO BLURRY VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH THE SAME MODEL LENS AND SAME MODEL AND SAME DIOPTER LENS. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT IS DOING FINE. THE PRE-OP UNCORRECTED AND BEST CORRECTED VISUAL ACUITY WAS 20/60. THE PRE-OP UNCORRECTED AND BEST CORRECTED VISUAL ACUITY WAS 20/25. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 20678254 ↗InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT IS REPORTED THAT PRELOADED MONOFOCAL TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO UNKNOWN REASON. THE PRODUCT IS BEING RETURNED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Eye Injury
MAUDE report 17592609 ↗MalfunctionSep 6, 2022Break; Inaccurate Delivery; Break; Inaccurate Delivery
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS PARTIALLY DELIVERED ON PATIENT'S LEFT EYE, BUT BENT/BROKEN HAPTIC. SAME MODEL AND DIOPTER SIZE PRODUCT WAS USED AS THE BACK-UP IOL. IT WAS NOTED THAT NO ADDITIONAL INFORMATION WILL BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15359086 ↗InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A TECNIS EYHANCE INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT'S OPERATIVE EYE. THE REASON FOR THE EXCHANGE WAS NOT GIVEN. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Eye Injury
MAUDE report 12485272 ↗
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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