TECNIS SIMPLICITY DCB00 (REF DCB0000260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474636200), received between Dec 10, 2020 and Aug 25, 2026 — classified as 1 injury, 8 malfunctions.

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

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50441877 ↗
• InjuryJul 9, 2026Break

  IT WAS INITIALLY REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND TO BE DEFECTIVE DURING A PROCEDURE. THE LENS WAS FULLY INSERTED AND SUBSEQUENTLY REMOVED WITHIN THE SAME PROCEDURE DUE TO THE OBSERVED ISSUE DURING THE DEVICE'S IMPLEMENTATION OR APPLICATION. ADDITIONAL INFORMATION WAS PROVIDED AND REPORTED THAT THE INTRAOCULAR LENS WAS SUCCESSFULLY IMPLANTED INTO THE PATIENT'S OPERATIVE EYE. SUBSEQUENTLY, THE LENS WAS REMOVED, HOWEVER, IT WAS NOT ATTRIBUTED TO A PRODUCT DEFECT. IT WAS REPORTED THAT A RUPTURE OF THE INTRAOCULAR CAPTURE RESULTED IN MIGRATION OF THE LENS INTO THE POSTERIOR SEGMENT OF THE EYE. IN CONSIDERATION OF THE PATIENT'S CLINICAL CONDITION, THE SURGEON ELECTED TO EXPLANT THE PREVIOUSLY IMPLANTED LENS AND LEAVE THE PATIENT APHAKIC DURING THE HEALING PERIOD. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25773422 ↗
• 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 23610107 ↗
• MalfunctionJun 10, 2025Scratched Material; Material Split, Cut or Torn; Scratched Material; Material Split, Cut or Torn

  IT WAS REPORTED BY THE SURGEON THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS TORN OR SCRATCHED. THE ISSUE WAS NOTICED DURING IMPLANTATION/APPLICATION OF THE LENS. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE. THE PATIENT STATUS WAS TEMPORARILY IMPAIRED. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180548 ↗
• MalfunctionOct 3, 2023Crack; Crack

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THE CARTRIDGE TIP WAS DEFECTIVE. THE SURGERY WAS COMPLETED SUCCESSFULLY, NO ADDITIONAL SURGERY STEPS WERE NEEDED. THROUGH FOLLOW-UP WE LEARNED THAT THE DEFECTIVE CARTRIDGE TIP WAS NOTICED DURING CONTACT WITH THE PATIENT'S EYE; HOWEVER, THE PATIENT WAS NOT AFFECTED OR INJURED IN ANY WAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865878 ↗
• MalfunctionJun 13, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS NOT STERILE. THE LENS HAD NO PATIENT CONTACT AND THE SURGERY HAD TO BE CANCELLED. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 17121943 ↗
• MalfunctionDec 28, 2021Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) DEVICE HAD A LOADING PROBLEM THAT LED TO THE LENS LEADING HAPTIC BEING KINKED. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13102490 ↗
• MalfunctionNov 18, 2021Crack; Device Contaminated During Manufacture or Shipping; Crack; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) INJECTOR WAS BROKEN BUT THERE WAS NO IMPACT ON THE PATIENT. ACCOUNT PROVIDED THAT THE CARTRIDGE TIP WAS IN CONTACT WITH THE EYE AND RESIDUE FROM A PIECE OF PLASTIC THAT BROKE-OFF GOT INTO THE PATIENT'S OPERATIVE EYE. THE SURGEON WAS ABLE TO PROCEED WITH THE SURGERY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12841097 ↗
• MalfunctionDec 10, 2020Contamination; Contamination

  AFTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE IT WAS REPORTED THE DOCTOR NOTICED A SMALL GRAY PARTICLE OR MATERIAL IN THE EYE. THE PARTICLE WAS EVACUATED RIGHT AWAY. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), NO UNPLANNED VITRECTOMY, THE REPORTED GREY PARTICLE, OR MATERIAL IS NOT AVAILABLE FOR TESTING. PATIENT OUTCOME WAS REPORTED AS EXCELLENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10988962 ↗