TECNIS SIMPLICITY DCB00 (REF DCB0000065)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SMPLCTY TECNIS 1PC CLR MONO 6.5D · 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 05050474635814), received between Apr 14, 2023 and Apr 14, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Opacification” (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 Opacification2
- Scratched Material2
- Break1
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, 2023Break; Material Opacification; Scratched Material; Break; Material Opacification; Scratched Material
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD SCRATCHES AND MULTIPLE DEPOSITS OR BUMPS ON THE EDGE OF THE OPTIC AFTER THE IOL WAS IMPLANTED. THE EDGE OF THE OPTIC SEEMED TO BE ROUGH/IRREGULAR IN THAT AREA. THE SURGEON COULD NOT ASPIRATE THEM OFF THE IOL, NOR COULD SHE SCRAPE THEM OFF COMPLETELY AS THEY WERE STUCK TO THE IOL. THE SURGEON FEELS IT IS LIKELY ABERRATIONS/DEFECTS IN THE IOL PRODUCTION AND THE DEPOSITS ARE POSSIBLY IOL MATERIAL, AND NOT FOREIGN MATERIAL. THE IOL WAS IMPLANTED WITH EASE, NO RESISTANCE, AND SEEMINGLY NORMAL DELIVERY. THE PRODUCT DEVICE WAS DISCARDED. THERE WAS NO OBSERVATION OF ANY PLUNGER OVERRIDE OR PROBLEM. ON POST-OP DAY 1 (POD1), IT WAS REPORTED THAT THE PATIENT IS DOING WELL. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16748192 ↗MalfunctionApr 14, 2023Material Opacification; Scratched Material; Material Opacification; Scratched Material
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD SCRATCHES AND DEPOSITS ON THE OPTIC WHEN OPENED AND VIEWED UNDER THE MICROSCOPE. THERE WAS NO PATIENT CONTACT. THE PRODUCT HAS BEEN DISCARDED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16748173 ↗
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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