TECNIS SIMPLICITY DCB00 (REF DCB0000295)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SMPLCTY TECNIS 1PC CLR MONO 29.5D · Class 3 · Implant
All models of TECNIS SIMPLICITY (112)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 05050474636279), received between Jun 6, 2023 and Mar 12, 2026 — 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. 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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Ejection 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.
InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. AN A-SCAN MEASUREMENT SHOWED AN IMPROPER IOL IMPLANTED AND THE PATIENT ENDED UP -9.0. THE REPLACEMENT LENS WAS THE SAME MODEL BUT WITH A LOWER POWER (20.5 D). BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OPERATIVE: HAND MOTION VISION AND BSCVA POST-OPERATIVE: CF (COUNTING FINGERS) AT 2 FEET. THE PATIENT'S CURRENT OUTCOME IS UNKNOWN/NOT PROVIDED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 24580053 ↗MalfunctionJul 1, 2025Ejection Problem; Ejection Problem
IT WAS REPORTED THAT THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) DID NOT DEPLOY CORRECTLY IN THE OPERATING ROOM. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22379116 ↗MalfunctionJun 6, 2023Break; Break
IT WAS REPORTED THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) HAD A CRACK AFTER IT WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE. THE CRACK WAS DEEPER THAN A SCRATCH. THIS IS NOT A USE ERROR. THE IOL REMAINS IMPLANTED AS THE DOCTOR WAS NOT COMFORTABLE REMOVING IT AS HE DID NOT WANT TO EXPERIENCE COMPLICATIONS. VISUAL EFFECTS TO BE DETERMINED. FUTURE SURGICAL/MEDICAL INTERVENTION IS BEING CONSIDERED. THERE WERE NO OTHER COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT OR SUTURES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17075239 ↗
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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