TECNIS SIMPLICITY DCB00 (REF DCB0000320)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474636323), received between May 2, 2023 and May 16, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2023Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam

  IT WAS REPORTED THE PRE-LOADED DCB00 MODEL INTRAOCULAR LENS (IOL) TRAILING HAPTIC WAS WEDGED BETWEEN THE CARTRIDGE AND PADDLE, AND WAS UNABLE TO RELEASE. ULTIMATELY, THE HAPTIC BROKE OFF AND THE IOL HAD TO BE EXPLANTED. THERE WAS PATIENT CONTACT HOWEVER, EXTENT OF CONTACT IS UNKNOWN. THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING J&J BACKUP LENS WITH THE SAME MODEL AND DIOPTER SIZE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16943372 ↗
• MalfunctionMay 2, 2023Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT AT THE TIME OF IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL), WHEN SLIDING THE IMPLANT SYSTEM PLUNGER, THE LENS GOT STUCK ON THE TIP OF THE CARTRIDGE AND WHEN TRYING TO PASS THE LENS, IT WAS DAMAGED. ONLY THE CARTRIDGE TIP MADE CONTACT WITH THE EYE. THERE WAS NO BACK-UP LENS OF THE SAME DEGREE, SO THE PATIENT HAD TO REMAIN APHAKIC (WITHOUT LENS) UNTIL THE ARRIVAL OF THE NEW LENS. THE PATIENT REMAINED APHAKIC FOR TWO DAYS AND IT IS NOTED THAT THE LENS PLACEMENT SURGERY IS NOT YET PERFORMED AND PATIENT IS TEMPORARILY IMPAIRED. NO INCISION ENLARGEMENT OR VITRECTOMY REQUIRED. IT IS NOTED THAT THE END-USER SOUGHT MEDICAL CARE. STANDARD POST-OP MEDICATION WAS PRESCRIBED. INSTRUCTIONS FOR USE WERE FOLLOWED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT ANOTHER JOHNSON AND JOHNSON IOL (ZCB, 32.0D) WAS IMPLANTED IN THE RIGHT EYE DURING A NEW STANDARD SURGERY ON (B)(6) 2023, WHICH INVOLVED ANESTHESIA, SEDATION, INCISION (MAIN AND PARACENTESIS). THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. THE PATIENT OUTCOME IS "GOOD EVOLUTION". THE PATIENT WAS DISCHARGED UNEVENTFULLY AND THERE ARE NO PLANNED INTERVENTIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16856107 ↗