TECNIS SIMPLICITY DCB00 (REF DCB0000290)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474636262), received between Dec 30, 2020 and Nov 7, 2025 — 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DCB00 WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE. THE PATIENT HAD TO HOLD THINGS REALLY CLOSE TO BE ABLE TO SEE ANYTHING. PATIENT NOT ABLE TO FUNCTION DUE TO MYOPIA AGGRAVATING HIS CENTRAL SCOTOMA. THE PATIENT HAS A HISTORY OF MYOPIC LASIK AND MULTIPLE RETINAL PROCEDURES, INCLUDING PARS PLANA VITRECTOMY (PPV) IN THE RIGHT EYE PRIOR TO CATARACT SURGERY. THE LENS WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE DUE TO PATIENT'S PREFERENCE TO CHANGE VISION TARGET FROM NEAR TO DISTANCE AND AS THE PATIENT DID NOT LIKE MYOPIA. THE REPLACEMENT LENS WAS THE SAME MODEL DCB00 WITH 24. 0 DIOPTER. THERE WERE NO CAPSULE TEAR, UNPLANNED VITRECTOMY , INCISION ENLARGEMENT AND SUTURES. FOLLOWING REPLACEMENT LENS IMPLANTATION, THE PATIENT¿S VISUAL ACUITY (VA) WAS 20/400. THE MANIFEST REFRACTION (MRX) WAS -0.25 D SPHERE AND -0.50 D CYLINDER AT 135°, VA: 20/400. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION OUTSIDE OF STANDARD CARE WAS REQUIRED. IT WAS STATED THAT THE LENS DID NOT CONTRIBUTE TO THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 23503993 ↗
• MalfunctionMay 13, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT A DCB00 MODEL INTRAOCULAR LENS(IOL) WAS DEFECTIVE, MADE POPPING SOUND AND AS DOCTOR TRIED TO IMPLANT THE LENS, BUT IT WOULDN'T COME OUT. THERE WAS PATIENT CONTACT AND NO PATIENT INJURY. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822309 ↗
• MalfunctionDec 30, 2020Crack; Crack

  REPORT RECEIVED INDICATING THE CARTRIDGE OF THE DCB00 (PRELOADED DEVICE) CRACKED AS THE INTRAOCULAR LENS (IOL) WAS BEING INSERTED INTO THE LEFT EYE. SURGEON NOTICED THE TIP WAS CRACKED WHILE INSERTING. THE IOL WAS PLACED IN ANOTHER CARTRIDGE AND WAS INSERTED IN THE EYE WITH NO PROBLEMS. NO INCISION ENLARGEMENT REQUIRED. THE IOL REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11098757 ↗