TECNIS SIMPLICITY DIB00 (REF DIB00U0300)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474731967), received between Apr 14, 2023 and Aug 14, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2024Device Damaged Prior to Use; Manufacturing, Packaging or Shipping Problem; Appropriate Device Problem Term/Code Not Available; Device Damaged Prior to Use; Manufacturing, Packaging or Shipping Problem; Appropriate Device Problem Term/Code Not Available

  IT IS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), A DIB00 30.0, APPEARED TO BE DAMAGED WITH SOMETHING SPILLED ON IT AND DRIED. THERE WAS NO PATIENT CONTACT. FURTHER INFORMATION SUGGESTS THAT IT LOOKED LIKE A CAN OF SODA WAS SPILLED ON THE LENS. ADDITIONALLY, THE OUTER SHIPPING BOX APPEARED TO HAVE BEEN REPACKAGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986812 ↗
• MalfunctionMay 8, 2023Crack; Crack

  IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO A PATIENT¿S FIST EYE, THE BEVEL APPEARED MISSHAPEN, CARTRIDGE TIP WAS DEFORMED/CRACKED; HOWEVER, THE SURGEON WAS ABLE TO SUCCESSFULLY DELIVER/IMPLANT THE LENS WITHOUT INCIDENT. THERE WAS CONTACT WITH PATIENT¿S EYE. NO FURTHER ATTENTION WAS NEEDED, NO DELAY REPORTED, NO SUTURES REQUIRED, AND IT WAS CONFIRMED THAT THE DIRECTIONS WERE FOLLOWED. THERE WAS NO PATIENT INJURY, NO IMPAIRMENT AND THE ISSUE DID NOT AFFECT PATIENT¿S DAILY ACTIVITIES. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16891956 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DIB00 INTRAOCULAR LENS WAS IMPLANTED. THE PATIENT IS ESSENTIALLY PLANO AND 20/20 IN EACH EYE AND HAPPY THAT HE DID SURGERY BUT PERSISTENTLY BOTHERED A 360 DEGREE MID PERIPHERAL HALO/DISTORTION EFFECT IN EACH EYE. IT GOES AWAY WITH SUNGLASSES. THE PATIENT WAS ALSO BOTHERED BY ARTIFICIAL LIGHTING IN ANY SCENARIO, NATURAL LIGHT SEEMS TO BE OK. ADDITIONAL INFORMATION STATED THAT PATIENT HAD MIDPERIPHERAL 360 DEGREE DISTORTION, BLURRINESS AROUND THE EDGES OF THINGS, LIGHT SENSITIVITY WITH ARTIFICIAL AND INDOOR LIGHTING AND DAILY ACTIVITIES ARE SIGNIFICANTLY AFFECTED. PATIENTS PRE OP BEST CORRECED VISUAL ACUITY (BCVA) WAS 20/20 OU, POST-OP UNCORRECTED AND BEST CORRECTED VISUAL ACUITY, POST OP VASC WAS 20/25 AND 20/20, BCVA WAS 20/20 OU. UPON FURTHER FOLLOW UP, IT WAS INFORMED THAT PATIENT HAD REPEATED SHORT TREATMENT WITH PREDNISOLONE PHOSPHATE/BROMFENAX COMBINATION DROP TID X 1 WEEK, THEN TWICE A DAY FOR 1 WEEK (NO APPARENT EFFECT). PATIENT HAS PERSISTENT SYMPTOMS, RECOMMENDED TRIAL OF VUITY BUT NOT CLEAR IF PATIENT HAS PICKED UP, DUE BACK IN CLINIC AT THE TIME OF THIS REPORT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 16748013 ↗