TECNIS SIMPLICITY DCB00 (REF DCB0000315)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474636316), received between Feb 9, 2021 and Apr 3, 2025 — classified as 2 injuries, 5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2025Crack; Crack

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) INJECTOR TIP TORE DURING IMPLANTATION. THERE WAS NO INJURY TO THE PATIENT AND THE IOL WAS IMPLANTED WITHOUT ANY OTHER ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21763579 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED, THERE WAS AN UNEXPECTED POST-OPERATIVE REFRACTION. ACCOUNT INDICATED THAT THE SURGERY WAS COMPLETED WITHOUT ANY COMPLICATIONS. TARGET REFRACTION: 0 PRE-OPERATIVE REFRACTION: +7.5 -1.75 AT 172 DEGREES POST-OPERATIVE REFRACTION ON (B)(6) 2024: RA -2.75 -2.5 AT 158 DEGREES = 0.4 THE PATIENT EXPERIENCED A GLAUCOMA ATTACK WITH A VERY SHALLOW ANTERIOR CHAMBER. A POST YTTRIUM ALUMINUM GARNET (YAG-IE) CATARACT SURGERY WAS PERFORMED TO PREVENT FURTHER GLAUCOMA ATTACKS. THE PATIENT IS AMBLYOPIC, AND MYOPIA CANNOT BE MAINTAINED ACCORDING TO THE SURGEON. THROUGH FOLLOW-UP VISITS, IT WAS LEARNED THAT THE PATIENT DEVELOPED GLAUCOMA AFTER THE SURGERY. THE IOL WAS EXPLANTED ON (B)(6) 2024 AND REPLACED WITH A DCB00 MODEL IOL OF 24 DIOPTER, SERIAL NUMBER (B)(6). THE EXPLANTED IOL WAS DISCARDED. CURRENTLY, THERE IS NO NEW INFORMATION ON THE POST-OPERATIVE VISUAL ACUITY. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Glaucoma; Visual Impairment

  MAUDE report 21214069 ↗
• MalfunctionDec 20, 2023Crack; Use of Device Problem; Crack; Use of Device Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) CARTRIDGE TIP CRACKED SLIGHTLY DURING LENS INSERTION. IT WAS FURTHER DESCRIBED AS A "STRESS LINE" AT THE TIP OF THE CARTRIDGE. THE SURGEON CONTINUED TO IMPLANT THE LENS AND THERE WAS NO PATIENT INJURY OR PATIENT IMPACT. THE LENS REMAINS IMPLANTED. THE ISSUE OCCURRED SOMETIME BETWEEN NOV 16, 2023 AND DEC 07, 2023, HOWEVER NO SPECIFIC EVENT DATE IS KNOWN. THE SALES REPRESENTATIVE REPORTED THAT IT WAS NOTICED THAT THE CARTRIDGES ARE BEING OVERFILLED WITH BALANCED SALT SOLUTION (BSS) BY THE TECHNICIANS AND TRAINING WAS PROVIDED, HOWEVER THE SALES REPRESENTATIVE WAS UNSURE IF THAT WAS RELATED TO THIS ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369976 ↗
• MalfunctionJun 2, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WOULD NOT PUSH OUT OF THE INSERTER AND THE HAPTIC WAS BROKEN. THERE WAS NO CONTACT WITH THE PATIENT'S OPERATIVE EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14581897 ↗
• MalfunctionJan 26, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FOUND UNFOLDED PRIOR TO INSERTION INTO THE LEFT EYE OF A FEMALE PATIENT. IT WAS INDICATED THAT THE LENS WAS PARTIALLY INSERTED. THE IOL WAS REMOVED FROM THE EYE DURING SAME PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13353994 ↗
• MalfunctionDec 29, 2021Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS OPENED ON FIELD, HOWEVER, THE SURGEON WAS UNSURE OF THE INTEGRITY OF IT'S HAPTIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13104122 ↗
• InjuryFeb 9, 2021Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED MALFUNCTION OF THE INSERTER CAUSED A DEFECT IN THE LENS. THE INCISION WAS ENLARGED AND A SUTURE WAS REQUIRED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION STATING WHEN CERTIFIED SURGICAL TECHNOLOGIST (CST) ADVANCED THE INJECTOR, IT LOCKED IN PLACE SHORT OF ENGAGING SCREWS. THE DOCTOR COULD NOT GET IT TO ADVANCE. DISENGAGED, ADDED MORE PROVISC, TRIED AGAIN, AND THEN IT ADVANCED. LENS NOTED BY SURGEON TO BE DAMAGED INSIDE OF THE EYE. INCISION EXPANDED AND THE DAMAGED LENS REMOVED IN ONE PIECE. THE BACKUP LENS USED TO COMPLETE THE PROCEDURE WAS THE SAME MODEL AND DIOPTER SIZE. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS: PATIENT INJURY NOT DETERMINED ON DAY OF SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11305423 ↗