TECNIS SIMPLICITY DIB00 (REF DIB00U0285)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SIMPLICITY TECNIS EYHANCE U 28.5D · Class 3 · Implant
All models of TECNIS SIMPLICITY (112)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474731936), received between Feb 3, 2022 and Apr 14, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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 16, 2026.
Most reported problems
Device problems
- Crack1
- Material Split, Cut or Torn1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) SPLIT IN HALF. THERE WAS PATIENT CONTACT WITH THE LEFT EYE. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. A BACK UP LENS WAS USED (SAME MODEL AND DIOPTER). NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16748055 ↗MalfunctionFeb 3, 2022Crack; Mechanical Problem; Crack; Mechanical Problem
IT WAS REPORTED THAT THE PLUNGER OF THE PRELOADED DEVICE INVERTED THAT IT OVERRODE THE INTRAOCULAR LENS (IOL) AND CRACKED THE TIP OF THE CARTRIDGE. THERE WAS CONTACT WITH PATIENT'S LEFT EYE AND THE EVENT WAS OBSERVED JUST PRIOR TO IMPLANTATION OF THE LENS. HOWEVER, THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13447960 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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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