TECNIS SIMPLICITY DCB00 (REF DCB0000275)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474636231), received between May 3, 2021 and May 1, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT AFTER IMPLANTING THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE SURGEON NOTED THERE WAS A DEFECT WITHIN THE LENS. THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21946153 ↗
• MalfunctionSep 27, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS NOT ABLE TO BE IMPLANTED DUE TO THE INCISION SIZE IN THE PATIENT'S RIGHT EYE. THE DOCTOR INSERTED THE CARTRIDGE TIP INTO THE EYE. THE INCISION MAY HAVE BEEN TOO SMALL AND IT SEEMED THE CARTRIDGE WAS INSIDE THE EYE BUT IT¿S DIFFICULT TO CONFIRM. REPORTEDLY, THE LENS CAME OUT OF THE INJECTOR AND PUSHED THE INJECTOR BACK AS THE LENS WAS BEING PLACED INTO THE EYE. WHEN THE DOCTOR BEGAN TO TWIST SOMEHOW THE INJECTOR CAME OUT OF THE INCISION. THE IOL WAS NOT FULLY INSERTED AND WAS CAUGHT IN THE INCISION. THE IOL WAS NOT FULLY INSERTED AND WAS CAUGHT IN THE INCISION. THE DOCTOR CAREFULLY REMOVED THE IOL FROM THE INCISION USING ADDITIONAL MANEUVERS. THE ISSUE MAY HAVE BEEN RELATED TO USE ERROR BUT IT¿S DIFFICULT TO SAY. THE DOCTOR HAD TO SWITCH TO A BACKUP DCB00 OF THE SAME DIOPTER AND WIDEN THE INCISION. THE DOCTOR SAID THAT IT¿S IMPOSSIBLE TO SAY WHETHER WE SEND HIM A BAD PRODUCT OR IF IT'S HUMAN ERROR. HIS INCISION WAS 2.3 MM (MILLIMETER). THE IOL IS A HIGHER DIOPTER 27.5 SO HE HAD TO ENLARGE THE INCISION TO INSERT THE LENS. THERE WERE NO ADVERSE EFFECTS. THE PATIENT¿S PRESSURE 1 DAY POSTOP WAS 34 THEN WENT DO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20317559 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED THERE WAS A HAPTIC DAMAGED OF THE INTRAOCULAR LENS. THE PROBLEM WAS FOUND DURING HANDLING/ PRIOR TO INSERTION OF LENS INTO THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610921 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REFRACTIVE SURPRISE WITH THE PATIENT'S LEFT EYE (-5.5) POST IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). THE IOL WAS EXPLANTED ON A LATER DATE. SUTURES AND VITRECTOMY WERE REQUIRED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Visual Impairment

  MAUDE report 18520310 ↗
• MalfunctionDec 26, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE DEPLOYMENT OF THE PRELOADED INTRAOCULAR LENS (IOL) INTO THE CAPSULAR BAG, DAMAGE WAS OBSERVED TO THE PROXIMAL LOOP WHICH WAS FOUND FREE IN THE ANTERIOR CHAMBER. THE DAMAGED IOL WAS REMOVED AND REPLACED WITH A NEW LENS OF THE SAME MODEL AND POWER. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18395442 ↗
• MalfunctionAug 31, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FAULTY. NO FURTHER INFORMATION WAS PROVIDED. TWO LENSES WITH THE SAME ISSUE WERE REPORTED. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER LENS SERIAL NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17667365 ↗
• MalfunctionAug 31, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FAULTY. NO FURTHER INFORMATION WAS PROVIDED. TWO LENSES WITH THE SAME ISSUE WERE REPORTED. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER LENS SERIAL NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17667364 ↗
• MalfunctionJun 19, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PLUNGER GOT STUCK AND CUSTOMER WAS UNABLE TO ADVANCE THE PRELOADED INTRAOCULAR LENS (IOL). UPON EXAMINATION, THE OPTIC APPEARED TO BE DAMAGED BY THE PLUNGER SO THE DECISION WAS MADE TO OPEN A SECOND DEVICE OF THE SAME MODEL, DCB00. THE SAME THING HAPPENED AGAIN AND THE ACCOUNT IMPLANTED A DIFFERENT MODEL LENS INSTEAD, ZCB00. THE PROCESS OF PREPARING THE LENSES WERE AS RECOMMENDED, CHAMBER FILLED WITH BALANCED SALT SOLUTION (BSS), SMALL AMOUNT OF PROVISC TO THE TIP AND IN BOTH LENSES, DEVICE ADVANCEMENT AFTER MORE THAN 30 SECONDS. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SECOND DCB00. A SEPARATE REPORT IS BEING SUBMITTED FOR THE FIRST DCB00 INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159891 ↗
• MalfunctionJun 19, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PLUNGER GOT STUCK AND CUSTOMER WAS UNABLE TO ADVANCE THE PRELOADED INTRAOCULAR LENS (IOL). UPON EXAMINATION, THE OPTIC APPEARED TO BE DAMAGED BY THE PLUNGER SO THE DECISION WAS MADE TO OPEN A SECOND DEVICE OF THE SAME MODEL, DCB00. THE SAME THING HAPPENED AGAIN AND THE ACCOUNT IMPLANTED A DIFFERENT MODEL LENS INSTEAD, ZCB00. THE PROCESS OF PREPARING THE LENSES WERE AS RECOMMENDED, CHAMBER FILLED WITH BALANCED SALT SOLUTION (BSS), SMALL AMOUNT OF PROVISC TO THE TIP AND IN BOTH LENSES, DEVICE ADVANCEMENT AFTER MORE THAN 30 SECONDS. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR THE FIRST DCB00. A SEPARATE REPORT IS BEING SUBMITTED FOR THE SECOND DCB00 INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159890 ↗
• MalfunctionMay 3, 2021Break; Break

  IT WAS REPORTED THAT A TECNIS SIMPLCTY PRELOADED INTRAOCULAR LENS (IOL) WAS DAMAGED AS IMPLANTED IN THE PATIENT'S EYE. THE LENS WAS REMOVED AND REPLACED WITH A BACK UP LENS DURING THE INITIAL PROCEDURE. REPORTEDLY, THE PATIENT IS DOING FINE POST-SURGERY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766692 ↗