TECNIS SIMPLICITY DCB00 (REF DCB0000225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 05050474636132), received between Sep 16, 2020 and Aug 23, 2026 — classified as 20 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Break” (37 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50393996 ↗
• MalfunctionJul 27, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50027955 ↗
• MalfunctionApr 20, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAS BEEN IDENTIFIED AS DEFECTIVE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933729 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED IN THE SHOOTER AND NOT IMPLANTED. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP LENS OF THE SAME MODEL AND DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975032 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, AFTER INSERTION AND PLACEMENT OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) IN THE PATIENT¿S SECOND EYE, A POSTERIOR CAPSULAR TEAR WAS OBSERVED IN THE LOWER-NASAL QUADRANT, SPANNING SEVERAL CLOCK HOURS AND POSSIBLY AT THE SITE OF THE IOL¿S INITIAL POSITION. THE SURGEON REPOSITIONED THE HAPTICS AWAY FROM THE TEAR AND CONFIRMED THAT THE IOL WAS STABLE. THE SURGEON PROCEEDED WITH REMOVING THE VISCOELASTIC AND CLOSING THE CASE. NO FURTHER DETAILS WERE PROVIDED REGARDING THE PATIENT¿S CONDITION BEYOND THE OBSERVED TEAR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 23898980 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DCB00 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED TO EXPLANTED FROM THE PATIENT'S EYE; INFORMATION REGARDING THE REPLACEMENT IOL WAS NOT PROVIDED. PATIENT PROGNOSIS POST LENS EXCHANGE IS ALSO UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 23822973 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THAT LENS WAS FOUND DAMAGED DURING SURGERY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769863 ↗
• MalfunctionNov 20, 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 23610348 ↗
• MalfunctionNov 7, 2025Contamination; Contamination

  IT WAS REPORTED THAT WHEN INSERTING THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE, A SUBSTANCE WAS OBSERVED ON THE OPTIC AND THE SUBSTANCE WAS REMOVED. THE LENS WAS FULLY INSERTED AND REMAINS IMPLANTED. THE PATIENT'S STATUS WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23504285 ↗
• InjuryNov 5, 2025Device Difficult to Setup or Prepare; Scratched Material; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Scratched Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT LENS GOT SCRATCHED AND TORN BY THE SIMPLICITY PRELOADED SYSTEM WHILE SURGEON WAS TWISTING THE PLUNGER TO ADVANCE. A BACKUP LENS WAS USED. THERE WAS DELAY IN TREATMENT. THE PATIENT HAD POOR VISION. NO INTERVENTIONS WERE PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480924 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A SINGLE PIECE MONOFOCAL INTRAOCULAR LENS (IOL), THE SURGEON OBSERVED THAT THE TRAILING HAPTIC APPEARED THINNER IN COMPARISON TO THE LEADING HAPTIC. IT WAS NOTED THAT THERE WAS PATIENT CONTACT, BUT THE EXTENT OF CONTACT IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392416 ↗
• MalfunctionOct 20, 2025Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS RECEIVED BY THE CUSTOMER WITH A BROKEN UNIT CARTON BOX AND A DAMAGED BUCKET THAT CLOSES THE BOX, COMPROMISING THE STERILITY OF THE PRODUCT. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23343624 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED A "SHADOW ON THE LEFT" IN THEIR PERIPHERAL VISION. THE ISSUE DID NOT INTERFERE WITH THE PATIENT'S DAILY ACTIVITIES. THE LENS WAS EXPLANTED DURING A SECONDARY SURGERY, AND THE PATIENT RECOVERED FULLY WITHOUT THE NEED FOR UNPLANNED SURGICAL INTERVENTIONS. A NON-JOHNSON & JOHNSON LENS OF 21.5 DIOPTER WAS USED AS A REPLACEMENT IOL. NO MEDICATION OUTSIDE OF STANDARD OF CARE WAS REQUIRED AND NO PATIENT INJURY WAS REPORTED. IT WAS NOTED THAT THE DIRECTIONS FOR USE OF THE DEVICE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 22891175 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT WHILE PREPARING THE PRELOADED INTRAOCULAR LENS (IOL) FOR IMPLANT, THE HAPTIC WAS FOUND DAMAGED AND IOL WAS NOT USED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709645 ↗
• MalfunctionJul 17, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD MISFIRED AS THE CARTRIDGE TIP INSERTED INTO THE EYE. THERE WAS A TWO (2) MINUTE DELAY IN PROCEDURE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THE PATIENT'S STATUS WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538590 ↗
• MalfunctionJul 3, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) POSTERIOR HAPTIC WAS JAMMED BETWEEN THE PLUNGER AND THE INSERTER END TIP, AND THE SURGEON HAD MAXIMIZED THE TWISTING OF THE PLUNGER. THE DEVICE WAS DISCARDED. THROUGH ADDITIONAL INFORMATION PROVIDED, IT WAS LEARNED THERE WAS PATIENT CONTACT. THE INTRAOCULAR LENS WAS FULLY INSERTED. THE LEADING HAPTIC ENTERED THE CAPSULAR BAG AS EXPECTED, AND THE OPTIC WAS POSITIONED APPROPRIATELY. HOWEVER, THE ISSUE OCCURRED WITH THE POSTERIOR HAPTIC. THE TIP OF THE POSTERIOR HAPTIC BECAME LODGED BETWEEN THE PLUNGER AND THE INSERTER TIP, AND THE SURGEON HAD REACHED THE MAXIMUM TWISTING LIMIT ON THE PLUNGER. THE SURGEON WAS ABLE TO USE OTHER INSTRUMENTS FROM THE INTRAOCULAR SET TO CAREFULLY FREE THE LENS FROM THE INSERTER. FORTUNATELY, THE LENS REMAINED UNDAMAGED, AND THE SURGEON WAS SATISFIED WITH ITS FINAL PLACEMENT. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398559 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS BROKEN. THROUGH FOLLOW-UP, WE LEARNED THAT THERE WAS NO PATIENT INVOLVEMENT SINCE NO PART OF THE DEVICE WAS IN CONTACT WITH THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22333346 ↗
• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A MONOFOCAL INTRAOCULAR LENS (IOL), ONE OF THE HAPTICS WAS FOUND TO BE BROKEN. THE LENS WAS INITIALLY INSERTED INTO THE PATIENT, BUT AFTER IDENTIFYING THE BROKEN HAPTIC, IT WAS REMOVED AND REPLACED WITHOUT CAUSING HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303068 ↗
• MalfunctionJun 2, 2025Scratched Material; Scratched Material

  THE SURGERY CENTER REPORTED CENTRAL DEFECTIVE SCRATCH ON A MONOFOCAL INTRAOCULAR LENS (IOL). THE LENS WAS PUT IN THE PATIENT'S LEFT EYE, THEN REMOVED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER. NO MEDICAL OR SURGICAL INTERVENTIONS WERE NECESSARY, AND NO PATIENT INJURY WAS REPORTED. THE LENS IN QUESTION WAS DISCARDED AND IS UNAVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126707 ↗
• MalfunctionMay 14, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS PRIMED AND THE WHOLE LENS CRUMBLED UPON ADVANCING THE LENS. BACK UP LENS WAS USED TO COMPLETE THE PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020213 ↗
• MalfunctionApr 18, 2025Crack; Difficult to Fold, Unfold or Collapse; Crack; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) INJECTOR BROKE IN THE PATIENT'S OPERATIVE EYE AND THERE WAS AN UNFOLDING ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21869303 ↗
• MalfunctionApr 18, 2025Crack; Crack

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) CARTRIDGE CRACKED AFTER THE INSERTION. THE LENS WAS FULLY INSERTED. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE TIP OF THE CARTRIDGE WAS CRACKED ALONG THE LENGTH THAT THE CARTRIDGE. THE LENS ITSELF WAS INTACT; THEREFORE, THE LENS WAS FULLY INSERTED. THE PATIENT WAS NOT HARMED. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867014 ↗
• MalfunctionApr 3, 2025Crack; Ejection Problem; Crack; Ejection Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) TIP OF THE INSERTER WAS DEFECTIVE WHICH WAS OBSERVED WHEN THE LENS WAS DIFFICULT TO ADVANCE. THE LENS WAS ABLE TO BE USED. THEREFORE, THE IOL WAS FULLY INSERTED. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION OR ADDITIONAL MANEUVERS REQUIRED. THROUGH FOLLOW UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, SURGICAL INTERVENTION, OR ADDITIONAL MANEUVERS REQUIRED. ONLY THE LENS BOX IS AVAILABLE TO RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21768601 ↗
• MalfunctionApr 2, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT WHEN IMPLANTING THE INTRAOCULAR LENS (IOL) FOR THE PATIENT, THE PACKAGE OF IOL WAS OPENED, VISCOELASTIC WAS INJECTED INTO THE DEVICE. THE INJECTOR WAS ROTATED, THE LENS COULD NOT BE PUSHED, THE INCISION WAS WITHDRAWN, THE PRELOADED INTRAOCULAR LENS HAPTIC WAS BROKEN, THE USE WAS IMMEDIATELY STOPPED, AND OTHER LENS USED FOR THE PATIENT. REPORTEDLY THERE WAS NO PATIENT CONTACT WITH IOL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755532 ↗
• MalfunctionMar 24, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS SCRATCHED. THE SCRATCH WAS NOTICED DURING THE SURGERY ONCE THE LENS WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE. THE IOL WAS REMOVED AND REPLACED WITH A BACKUP OF THE SAME MODEL AND DIOPTER. IT IS THE SURGEON¿S OPINION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT WAS NOT INJURED. REPORTEDLY, THE PATIENT¿S POST-OP OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684521 ↗