TECNIS SIMPLICITY DCB00 (REF DCB0000095)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474635876), received between Jul 12, 2021 and Jun 9, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2025Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED BY SURGEON THAT A PRELOADED INTRAOCULAR LENS HAD SCRATCHES THAT WERE NOTICED AFTER IMPLANTATION. VISCOELASTIC WAS LEAKING OUT FROM THE SIDE OF THE CARTRIDGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22173138 ↗
• MalfunctionDec 13, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT DURING IMPLANTATION ON THE PATIENT'S LEFT EYE, A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS SCRATCHED. THE SURGEON FELT THE PATIENT WILL HAVE NO VISUAL IMPACT SINCE IT WAS ON THE PERIPHERY OF THE LENS, THEREFORE, THE LENS REMAINS IMPLANTED. THE DAILY ACTIVITIES ARE NOT SIGNIFICANTLY AFFECTED. T HE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20928613 ↗
• MalfunctionOct 14, 2021Break; Operating System Becomes Nonfunctional; Break; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE INJECTION OF THE INTRAOCULAR LENS (IOL). THE PISTON OF THE INJECTOR DID NOT PUSH THE LENS. AFTER SEVERAL ATTEMPTS THE LENS WAS INJECTED BUT THE OPTIC WAS SLIGHTLY DAMAGED ON THE UPPER EDGE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12636282 ↗
• MalfunctionJul 12, 2021Material Opacification; Material Opacification

  IT WAS REPORTED THAT AFTER INSERTION OF A MODEL DCB00 INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, THERE WAS A LARGE CENTRAL OPACITY OBSERVED. THE LENS WAS REMOVED FROM THE EYE AND A NEW LENS WAS PLACED. THERE WAS DELAY IN PROCEDURE AND THE INCISION WAS ENLARGED TO REMOVE THE LENS FROM PATIENT'S EYE, BUT NO VITRECTOMY OR SUTURES WERE REQUIRED. ADDITIONAL DETAILS RECEIVED STATES THAT LENS WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE AS THE SURGEON FELT IT WOULD IMPAIR PATIENTS VISION. SUSPECT PRODUCT WAS DISCARDED. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 12155712 ↗