TECNIS SIMPLICITY DCB00 (REF DCB0000060)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SMPLCTY TECNIS 1PC CLR MONO 6.0D · Class 3 · Implant
All models of TECNIS SIMPLICITY (112)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474635807), received between Sep 29, 2021 and Nov 19, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Reports received per month
Most reported problems
Device problems
- Break3
- Crack1
- Difficult to Fold, Unfold or Collapse1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND TO BE STIFF, AND THE HAPTICS WERE TAKING LONGER THAN USUAL TO UNFOLD IN THE EYE. THROUGH FOLLOW UP, WE LEARNED THAT ADDITIONAL SURGICAL MANEUVERS WERE REQUIRED TO POSITION THE IOL IN THE PATIENT'S EYE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23600638 ↗MalfunctionJan 10, 2025Break; Break
IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21132245 ↗MalfunctionNov 7, 2024Break; Mechanical Problem; Break; Mechanical Problem
IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) BROKE AS THE SURGEON WAS REMOVING IT FROM THE PACKAGING. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. ACCOUNT INDICATED THAT THE PROCEDURE WAS COMPLETED USING THE BACK UP IOL. THROUGH FOLLOW UP, WE LEARNED THAT THE CUSTOMER REPORTED THAT THE DEVICE, RATHER THAN THE IOL WAS FAULTY. THE PLUNGER PUSHED PAST THE IOL, SQUASHING IT TO THE SIDE OF THE APPLICATOR AND DAMAGING THE LENS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20626626 ↗MalfunctionDec 13, 2021Break; Break
IT WAS REPORTED THAT A HOLE OR A SCUFF MARK WAS OBSERVED IN THE CENTER OF AN INTRAOCULAR LENS (IOL) ONCE IT WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. THE DOCTOR CUT THE LENS OUT AND REPLACED IT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12987288 ↗MalfunctionSep 29, 2021Crack; Crack
IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) DEVICE CARTRIDGE BROKE. THE CARTRIDGE TIP HAD CONTACTED PATIENT'S RIGHT EYE. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED TO COMPLETE THE PROCEDURE AND THE PATIENT HAD RECOVERED. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12550358 ↗
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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