TECNIS SIMPLICITY DCB00 (REF DCB0000310)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SMPLCTY TECNIS 1PC CLR MONO 31.0D · 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 05050474636309), received between May 11, 2021 and Jan 13, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Fragmentation2
- Inaccurate Delivery1
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.
MalfunctionJan 13, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) LEAD HAPTIC WAS NOT VISIBLE OR DETACHED DURING THE HANDLING/ PREPARATION STAGE. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. THE MATERIAL WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16159535 ↗MalfunctionMay 11, 2021Material Fragmentation; Inaccurate Delivery; Material Fragmentation; Inaccurate Delivery
IT WAS REPORTED THAT THE SURGEON IMPLANTED PRELOADED INTRAOCULAR LENS (IOL) AND NOTICED ONE OF THE HAPTICS HAD BROKEN ONCE PLACED IN THE EYE. THE BROKEN HAPTIC WAS REMOVED BUT LEFT THE IOL IN THE EYE AS IT WAS STABLE. EVENT IS OBSERVED DURING IMPLANTATION/APPLICATION. PATIENT IS FULLY RECOVERED AND DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. THERE WERE NO INCISION ENLARGEMENT, VITRECTOMY NOR SUTURES REQUIRED. THERE WAS ALSO DELAY OF ONE HOUR IN PROCEDURE. FURTHER FOLLOW-UP CONFIRMED THAT THE SUSPECT IOL WAS A PRELOADED IOL. IT WAS LEARNED THAT THE IOL WAS NOT LEFT IN THE EYE. IT WAS ACTUALLY PARTIALLY DELIVERED INTO THE EYE AND THEN TAKEN OUT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11809603 ↗
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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