TECNIS SIMPLICITY DCB00 (REF DCB0000055)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SMPLCTY TECNIS 1PC CLR MONO 5.5D · Class 3 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474635791), received between Sep 16, 2021 and Nov 10, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Inaccurate Delivery” (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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Inaccurate Delivery3
Material Split, Cut or Torn3
Delivered as Unsterile Product1

Patient problems

No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 10, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) WAS CONTAMINATED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18114993 ↗
MalfunctionSep 16, 2021Inaccurate Delivery; Material Split, Cut or Torn; Inaccurate Delivery; Material Split, Cut or Torn
IT WAS REPORTED THAT WHEN THE SURGEON ADVANCED THE TECNIS SIMPLCTY PRELOADED INTRAOCULAR LENS (IOL), IT ADVANCED SIDEWAYS ONTO THE LENS INJECTOR CAUSING THE LENS TO TEAR. THE IOL WAS MANUALLY INSERTED WITH A SURGICAL INSTRUMENT INTO THE PATIENT'S LEFT EYE. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12479208 ↗
MalfunctionSep 16, 2021Inaccurate Delivery; Material Split, Cut or Torn; Inaccurate Delivery; Material Split, Cut or Torn
IT WAS INITIALLY REPORTED THAT THE PRELOADED DEVICE WAS DEFECTIVE AND WAS NOT USED. ADDITIONAL INFORMATION RECEIVED REVEALED THAT WHEN SURGEON ADVANCED THE INTRAOCULAR LENS (IOL), IT ADVANCED SIDEWAYS ONTO THE LENS INJECTOR, CAUSING THE LENS TO ACTUALLY TEAR. IT WAS STATED THAT ONLY THE CARTRIDGE TIP MADE CONTACT WITH THE PATIENT'S RIGHT EYE. THE SURGEON HAD TO MANUALLY INSERT A LENS WITH A SURGICAL INSTRUMENT. IT WAS INDICATED THAT THE LENS WAS FULLY INSERTED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12479076 ↗
MalfunctionSep 16, 2021Inaccurate Delivery; Material Split, Cut or Torn; Inaccurate Delivery; Material Split, Cut or Torn
IT WAS INITIALLY REPORTED THAT THE PRELOADED DEVICE WAS DEFECTIVE AND WAS NOT USED. ADDITIONAL INFORMATION RECEIVED REVEALED THAT WHEN SURGEON ADVANCED THE INTRAOCULAR LENS (IOL), IT ADVANCED SIDEWAYS ONTO THE LENS INJECTOR, CAUSING THE LENS TO ACTUALLY TEAR. IT WAS STATED THAT ONLY THE CARTRIDGE TIP MADE CONTACT WITH THE PATIENT'S LEFT EYE. THE SURGEON HAD TO MANUALLY INSERT A LENS WITH A SURGICAL INSTRUMENT. THE LENS WAS FULLY INSERTED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12479044 ↗

Device details

UDI-DI	`05050474635791`
Brand	TECNIS SIMPLICITY
Model	DCB00
Catalog no.	DCB0000055
Company	Johnson & Johnson Surgical Vision, Inc.
Product code	HQL · intraocular lens
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 10, 2023

Device type (GMDN): Posterior-chamber intraocular lens, pseudophakic

An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

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All intraocular lens devices →

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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