TECNIS IOL DIU300 (REF DIU300U205)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 20.5D CYL3.00 · Class 3 · Implant
- 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 05050474747739), received between Mar 24, 2022 and Dec 4, 2025 — classified as 1 injury, 2 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Delivered as Unsterile Product1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2025Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem
THE DIU300 MODEL INTRAOCULAR LENS (IOL) WAS RECEIVED BY THE ACCOUNT AND THEY EXPRESSED CONCERNS REGARDING THE STERILITY OF THE IOL. THE OUTER SHIPPING BOX SHOWED NO SIGNS OF DAMAGE. THE PRODUCT SEAL WAS FOUND BROKEN, RESULTING IN A CLEAR AND EASILY DETECTABLE BREACH OF THE STERILE BARRIER. THERE IS NO INDICATION OF PATIENT CONTACT WITH THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723452 ↗MalfunctionJul 24, 2023Break; Break
IT WAS REPORTED THAT PRIOR TO INSERTING THE PRELOADED INTRAOCULAR LENS (IOL) IN THE EYE, THE SURGEON NOTICED THAT THE HAPTIC WAS FOLDED UNDER THE LENS. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17377396 ↗InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR'S OFFICE REPORTED THEIR PATIENT EXPERIENCED REFRACTIVE SURPRISE AFTER IMPLANTING THE JOHNSON & JOHNSON INTRAOCULAR LENS (IOL) INTO THEIR RIGHT EYE. IT IS UNKNOWN IF THE OUTCOME IS SIGNIFICANTLY AFFECTING THE PATIENT¿S DAILY ACTIVITIES. THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE. UNKNOWN IF INCISION WAS ENLARGED. THERE WAS NO VITRECTOMY REQUIRED AND NO SUTURES. IT IS UNKNOWN IF MEDICATION WAS PRESCRIBED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 13874022 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.