TECNIS SIMPLICITY DCB00 (REF DCB0000085)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474635852), received between Mar 10, 2021 and Feb 23, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Scratched Material

  IT WAS REPORTED THAT A SINGLE PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS SCRATCHED. THERE WAS NO PATIENT CONTACT. THE PRODUCT IS NOT AVAILABLE SINCE IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416802 ↗
• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FOUND TO BE DAMAGED UPON OPENING. THE DAMAGED IOL WAS DISPOSED OF BY THE SURGEON, AND A DIFFERENT IOL WAS USED DURING THE SURGERY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918232 ↗
• InjuryDec 22, 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) WAS IMPLANTED AND LATER REMOVED. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PRODUCT WAS DISCARDED; THEREFORE, NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 23872123 ↗
• MalfunctionOct 30, 2023Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THROUGH FOLLOW-UP WE LEARNED THAT THE IOL WAS DAMAGED ON THE OPTIC PLATE, WITH A DEEP "CRACK" EXTENDING FROM THE POINT OF INSERTION OF ONE HAPTIC TO THE CENTER OF THE PLATE. THE IOL WAS REMOVE AND REPLACED WITH A NEW LENS. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035760 ↗
• MalfunctionMay 13, 2021Crack; Crack

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS WAS PUSHED OUT OF THE SIDE OF THE CARTRIDGE TIP WHEN THE SURGEON STARTED TWISTING THE INJECTOR KNOB. IT WAS CONFIRMED THAT THE TIP OF THE DEVICE CRACKED AND THE LENS WAS NOT ENTIRELY PUSHED THROUGH THE SIDE OF THE CARTRIDGE TIP. THE LENS DID NOT MAKE ANY CONTACT, HOWEVER, THE TIP OF THE CARTRIDGE WAS INSERTED INTO PATIENT'S RIGHT EYE. HOWEVER, THERE WAS NO PATIENT INJURY AND THE SURGEON REMOVED THE CARTRIDGE TIP FROM THE EYE WITHOUT ANY ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF SAME MODEL AND DIOPTER (SN_2710902012). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822956 ↗
• MalfunctionMar 10, 2021Inaccurate Delivery; Difficult to Advance; Mechanical Jam; Inaccurate Delivery; Difficult to Advance; Mechanical Jam

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) LOADED INCORRECTLY AND WOULD NOT INSERT COMPLETELY, AND KEPT POPPING OUT OF THE INCISION. ALSO, THE LENS WOULD NOT ADVANCE APPROPRIATELY INTO THE PATIENT'S EYE VIA THE CARTRIDGE. THE SECOND LENS USED (SAME MODEL AND DIOPTER) DID ADVANCE APPROPRIATELY. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. POST-OP PATIENT WAS STABLE WITH NO PAIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449814 ↗