TECNIS SIMPLICITY DCB00 (REF DCB0000070)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SMPLCTY TECNIS 1PC CLR MONO 7.0D · 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 05050474635821), received between Mar 27, 2023 and Sep 5, 2025 — classified as 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. 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
- Break1
- Difficult to Fold, Unfold or Collapse1
- Physical Resistance/Sticking1
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.
MalfunctionSep 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD ITS HAPTIC STUCK DURING THE SURGEON'S ATTEMPT TO INSERT IT INTO THE PATIENT'S OPERATIVE EYE. CONSEQUENTLY, THE LENS WAS ONLY PARTIALLY INSERTED AND COULD NOT BE FULLY IMPLANTED. IT WAS ALSO REPORTED THAT THE SURGEON INSERTED AND REMOVED THE LENS DURING THE SAME PROCEDURE. THE PATIENT RECOVERED FULLY. THERE WAS NO UNPLANNED VITRECTOMY OR OTHER COMPLICATIONS WERE NOTED. THROUGH ADDITIONAL INFORMATION RECEIVED, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACK UP LENS. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO MEDICATION OUTSIDE THE STANDARD OF CARE REQUIRED AND THE PATIENT WAS DOING GOOD AFTER SURGERY. THE PRODUCT IS NOT AVAILABLE TO RETURN FOR EVALUATION. NO OTHER INFORMATION WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22987030 ↗MalfunctionMar 27, 2023Break; Difficult to Fold, Unfold or Collapse; Break; Difficult to Fold, Unfold or Collapse
IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS FAULTY. THE HAPTIC WAS STUCK TO THE OPTIC AND WAS UNABLE TO UNFOLD IN THE EYE. THERE WAS ALSO A SMALL CRACK IN THE LENS. THE IOL WAS LEFT IN THE PATIENT'S EYE AS IT WAS OFF AXIS. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16619486 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page