TECNIS SIMPLICITY DIB00 (REF DIB00U0095)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474731547), received between Jun 29, 2022 and Sep 25, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionSep 25, 2026Break

  It was reported that, during implantation of a preloaded monofocal intraocular lens (IOL) in the patient's left eye, the leading haptic protruded from the injector/cartridge while the surgeon was advancing the lens for implantation. The issue was identified prior to insertion into the operative eye, during lens advancement, and no resistance was encountered. The affected IOL was not implanted, and the procedure was successfully completed using another lens of the same model and diopter. No patient injury was reported, no unplanned surgical interventions were required, and no medications outside the standard of care were prescribed. The patient was reported to have a normal prognosis and outcome. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893037 ↗
• MalfunctionNov 14, 2025Scratched Material; Scratched Material

  A SURGEON REPORTED THAT FOLLOWING IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), A PERIPHERAL ¿GRAZE¿ CONSISTENT WITH CONTACT FROM THE PLUNGER WAS OBSERVED ON THE LENS. THE GRAZE WAS VISIBLE INTRAOPERATIVELY BUT WAS REMOVED DURING THE IRRIGATION AND ASPIRATION (I&A) PROCEDURE. THE DEVICE HAD BEEN PREPARED WITH BALANCED SALT SOLUTION AND LEFT IN THE DWELL STATE FOR THREE MINUTES PRIOR TO ADVANCING THE PLUNGER. THE IOL REMAINED IMPLANTED AND WAS NOT EXPLANTED. THE SURGEON REPORTED ENCOUNTERING THIS ISSUE REPEATEDLY ACROSS TWO SEPARATE ACCOUNTS. ADDITIONAL INFORMATION CONFIRMED THAT THAT THE CARTRIDGE TIP AND THE HAPTIC/OPTIC WERE NOT DAMAGED AND THAT THE EVENT WAS NOT ATTRIBUTABLE TO USE ERROR. THERE WERE NO REPORTED POSTOPERATIVE VISUAL ISSUES RELATED TO THE GRAZE, NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED, AND NO PATIENT INJURY WAS REPORTED. ALL OBSERVED GRAZE MATERIAL WAS REMOVED AT I&A. NO FURTHER INFORMATION WAS PROVIDED. THIS SUBMISSION COVERS THE INCIDENT INVOLVING DIB00, SN (B)(6). TWO ADDITIONAL REPORTS ARE BEING SUBMITTED FOR SIMILAR INCIDENTS REPORTED AT TWO DIFFERENT ACCOUNTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560495 ↗
• MalfunctionMar 28, 2024Scratched Material; Scratched Material

  IT WAS REPORTED DURING HANDLING OF A PRELOADED PRODUCT THAT THE INTRAOCULAR LENS (IOL) WAS SCRATCHED. IOL WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18999295 ↗
• MalfunctionNov 30, 2023Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CATARACT SURGERY OF THE LEFT EYE. THE SURGERY WAS UNCOMPLICATED AND THE CATARACT WAS SUCCESSFULLY EMULSIFIED. THEN IMPLANTED THE TECNIS SIMPLICITY EYHANCE PRELOADED INTRAOCULAR LENS (IOL) FOLLOWING STANDARD LENS LOADING PRACTICES AND NO ABNORMALITIES WERE NOTED WITH THE LENS INJECTOR DURING THE LENS INJECTION PROCESS. UPON IMPLANTATION INTO THE CAPSULAR BAG, A LENS DEFECT WAS NOTED ON THE PERIPHERAL LENS OPTIC. THE DECISION WAS MADE TO EXPLANT THE LENS AND EXCHANGE IT WITH THE BACKUP SAME MODEL AND DIOPTER IOL, WHICH WAS INJECTED WITH NO ISSUES. THE PRODUCT WAS DESTROYED AND DISCARDED. ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WAS AN OPACITY NOTED IN THE PERIPHERAL LENS OPTIC THAT LOOKED SIMILAR TO A CRACK. BALANCED SALT SOLUTION (BSS) FROM ANOTHER MANUFACTURER WAS USED FOR CARTRIDGE LUBRICATION AT A ROOM TEMPERATURE. NO ADDITIVES USED. BSS WAS INTRODUCED VIA A CANNULA INTO THE HYDRATION PORT TO FILL THE CARTRIDGE COMPLETELY. JUST BSS WAS USED. IT WAS IN THE DWELL POSITION FOR ABOUT 3 MINUTES. SURGICAL TECH INTRODUCED BSS INTO HYDRATION PORT. ADVANCED PLUNGER UNTIL IT THREADS/CLICKS, THEN TURNED 1 TIMES PRIOR TO HANDING OFF TO SURG

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

  MAUDE report 18240550 ↗
• MalfunctionApr 26, 2023Break; Break

  IT WAS REPORTED THE PRE-LOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE. EXTENT OF PATIENT CONTACT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820037 ↗
• MalfunctionJul 7, 2022Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) POSSIBLY HAD A BENT/ BROKEN HAPTIC. ACCOUNT INDICATED THAT THE LEADING HAPTIC WAS PROTRUDING TOO FAR. THE LENS WAS INSERTED INTO THE PATIENT'S LEFT EYE; HOWEVER, THE SURGEON WAS UNABLE TO SEAT THE LENS PROPERLY. THE IOL WAS REMOVED FROM THE EYE. ANOTHER LENS OF THE SAME MODEL AND DIOPTER POWER WAS PLACED WITHOUT ANY INCIDENT. THE ORIGINAL IOL WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14951356 ↗
• MalfunctionJun 29, 2022Break; Mechanical Problem; Misassembled; Failure to Align; Break; Mechanical Problem; Misassembled; Failure to Align

  IT WAS REPORTED THAT THE PRELOADED DEVICE HAD LOADING ISSUE THAT IT STARTED CRUNCHING WHEN IT WAS TURNED AND SEEMED LIKE MISALIGNED. THERE WAS NO PATIENT CONTACT AND THE EVENT WAS OBSERVED DURING HANDLING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14849489 ↗