TECNIS SIMPLICITY DIB00 (REF DIB00U0220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 05050474731806), received between Jun 25, 2021 and May 11, 2026 — classified as 17 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, WAS REMOVED AFTER IT WAS PLACED IN THE PATIENT'S LEFT EYE DUE TO A TEAR IN THE CAPSULAR BAG AND NOT DUE TO A DAMAGE IN THE LENS. THERE WERE UNPLANNED VITRECTOMY AND SUTURES REQUIRED. FOR SUTURES, IT WAS THE DOCTOR'S STANDARD PRACTICE. MIOSTAT WAS GIVEN AS MEDICATION OUTSIDE THE STANDARD OF CARE. REPLACEMENT USED WAS OF NON-JOHNSON AND JOHNSON LENS (ALCON). PATIENT OUTCOME AND POST-OPERATIVE REFRACTION WITH THE NEW REPLACEMENT LENS WAS INDICATED AS DEFER TO THE SURGEON. THE COMPLAINT DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 25144455 ↗
• MalfunctionJan 30, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, WAS FOUND TO BE DEFECTIVE. THE LENS BECAME STUCK DURING THE PROCEDURE AND MADE CONTACT WITH THE PATIENT. NO HARM TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225677 ↗
• MalfunctionDec 30, 2025Break; Break

  THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS IDENTIFIED AS DEFECTIVE AND WAS NOT IMPLANTED INTO THE PATIENT. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED; HOWEVER, THE EMPTY BOX IS AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931063 ↗
• MalfunctionDec 17, 2025Material Opacification; Material Opacification

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), TWO VERY SMALL WHITE OPACITIES WERE OBSERVED IN THE IOL. BOTH SIDES OF THE LENS WERE POLISHED BY THE DOCTOR AND IT WAS DETERMINED TO BE AN ISSUE WITH THE LENS. VERITAS AND HEALON DUET WERE UTILIZED DURING THE SAME PROCEDURE BUT DID NOT CONTRIBUTE TO THE ISSUE. THE DEVICE REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828531 ↗
• InjuryNov 14, 2025Difficult to Insert; Ejection Problem; Difficult to Insert; Ejection Problem

  IT WAS INITIALLY REPORTED THAT A PRELOADED, MONOFOCAL INTRAOCULAR LENS (IOL) UNFOLDED CORRECTLY. ADDITIONAL INFORMATION INDICATED THAT THE LENS FAILED TO LOAD PROPERLY, LEADING TO CONTACT WITH THE PATIENT'S RIGHT EYE WITHOUT SUCCESSFUL IMPLANTATION. A VITRECTOMY WAS REQUIRED. A NON-JOHNSON & JOHNSON LENS WAS OF 21.0 DIOPTER WAS USED AS A REPLACEMENT. BALANCED SALT SOLUTION (BSS), ACCLIMATIZED TO THE OPERATING ROOM TEMPERATURE WAS USED DURING THE PROCEDURE. THE PATIENT OUTCOME IS UNKNOWN/ NOT PROVIDED. THE PRODUCT WILL NOT BE RETURNED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560008 ↗
• InjuryOct 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPRESSED DISSATISFACTION WITH POSTOPERATIVE VISUAL ACUITY AND TARGET REFRACTION FOLLOWING THE IMPLANTATION OF A PRELOADED SINGLE-PIECE SPHERICAL MONOFOCAL TECNIS SIMPLICITY TECNIS EYHANCE 22.0D INTRAOCULAR LENS (IOL) DURING A PROCEDURE CONDUCTED ON (B)(6) 2025. VISUAL ISSUES WERE INITIALLY NOTED ON (B)(6) 2025, LEADING TO A SECONDARY SURGERY ON (B)(6) 2025. DURING THIS SUBSEQUENT PROCEDURE, THE IMPLANTED LENS WAS EXPLANTED AND REPLACED WITH A DIFFERENT BRAND OF LENS. THE PATIENT HAS RECOVERED, AND NO UNPLANNED COMPLICATIONS SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 23273763 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT A PRELOADED LENS WITH MODEL DIBOO WAS EXPLANTED DUE TO A REFRACTIVE SURPRISE. THE LENS WAS SUBSEQUENTLY REMOVED DURING A SECONDARY SURGERY AND REPLACED WITH A DIFFERENT MODEL, A LOWER DIOPTER J&J MONOFOCAL IOL (MODEL AR40E +19.5). THERE WAS NO UNPLANNED INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY. THE PATIENT¿S CURRENT STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 23097829 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS, THE PATIENT EXPERIENCED A MYOPIC SURPRISE. AS A RESULT, THE LENS WAS REMOVED DURING A SECONDARY SURGERY AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL, BUT WITH A 1 DIOPTER DIFFERENCE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 23039528 ↗
• InjuryAug 29, 2025Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS WAS IMPLANTED AND EXPLANTED DUE TO CARTRIDGE SPLIT RESULTING IN A SCRATCHED LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922452 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED BY A CUSTOMER THAT THE LENS HAD BROKEN HAPTICS. REPORTEDLY CUSTOMERS DISCARDED THE LENS. THERE WAS NO PATIENT HARM OR ADVERSE EVENTS ASSOCIATED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909425 ↗
• MalfunctionAug 18, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT A PRELOADED LENS IMPLANT APPEARED DAMAGED PRIOR TO IMPLANTATION DURING HANDLING. THERE WAS NO CONTACT WITH THE PATIENT¿S EYE, AND NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829357 ↗
• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL EYHANCE INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THEN EXPLANTED DUE TO DAMAGE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22447812 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT A PRELOADED LENS WAS DAMAGED DURING IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971954 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO VISUAL DISTURBANCES. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A NON JNJ LENS. THE ISSUE WAS NOTICED DURING POST-OP EXAMINATION. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT HAD FULLY RECOVERED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 21910694 ↗
• MalfunctionMar 14, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S EYE. ONE OF THE HAPTICS WAS BROKEN OFF. THE IOL WAS REMOVED AND REPLACED WITH THE SAME MODEL AND DIOPTER. THE NEW LENS WAS INSERTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES. THE CUSTOMER PONDERED IF THE LENS WAS MISSING THE HAPTIC OR WAS THE HAPTIC TORN OFF WHEN INJECTING IT INTO THE EYE. THEY COULD NOT FIND THE HAPTIC IN THE INJECTOR OR ANYWHERE ELSE. THERE WAS NO INJURY TO THE PATIENT. NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT OR SUTURES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21611313 ↗
• MalfunctionMar 5, 2025Break; Failure to Advance; Break; Failure to Advance

  DURING PRODUCT HANDLING AND PRIOR TO INSERTION IN THE PATIENT'S OCULAR SINISTER (LEFT EYE), THE DIB00 MODEL INTRAOCULAR LENS (IOL) WOULD NOT ADVANCE IN THE INSERTER AND UPON EXAMINATION THE LENS WAS CRACKED/TORN. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21532283 ↗
• MalfunctionMar 4, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) THE SURGEON NOTICED A HAPTIC WAS MISSING. THE LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DURING A SECONDARY SURGERY. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO MEDICATION PRESCRIBED OUTSIDE OF STANDARD OF CARE. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21521092 ↗
• MalfunctionFeb 6, 2025Crack; Crack

  IT WAS REPORTED THAT THE PRELOADED LENS HAD PATIENT CONTACT AND THAT THE TIP OF THE CARTRIDGE WAS CRACKED. THIS WAS NOTICED DURING APPLICATION AND IMPLANTATION. THE LENS WAS PARTIALLY INSERTED AND THEN REMOVED. NO INJURY OR INTERVENTION WAS REQUIRED AND THE PATIENT FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21329470 ↗
• MalfunctionJan 2, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED BUT THEN REMOVED AND NOT USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21061516 ↗
• MalfunctionDec 13, 2024Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT A PRE-LOADED INTRAOCULAR LENS (IOL) INSERTER WAS ¿DEFORMED¿ OR ¿DAMAGED.¿ THE TIP OF THE INSERTER GOES IN A DIFFERENT DIRECTION (LIKE IT WAS SPLIT) AND APPARENTLY THE IOL CAME OUT OF THE SIDE. IT WAS NOTED THAT THERE WAS PATIENT CONTACT, LENS WAS FULLY INSERTED, DOCTOR NOTICED THE ISSUE OF SCRATCHED LENS AND THEN REMOVED AND REPLACED WITH THE BACKUP LENS, SAME DIOPTER SIZE. THE CUSTOMER ATTRIBUTED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. NO INJURY TO THE PATIENT, NO MEDICATION OUTSIDE OF STANDARD OF CARE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926886 ↗
• MalfunctionNov 11, 2024Break; Break

  THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED TO HAVE BEEN CRACKED. EXTENT OF PATIENT CONTACT WITH THE IOL IS UNKNOWN. THE PROCEDURE WAS COMPLETED USING A BACK-UP IOL THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20654147 ↗
• MalfunctionOct 25, 2024Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. THROUGH FOLLOW UP, IT WAS LEARNED THE PRODUCT IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20539676 ↗
• MalfunctionOct 22, 2024Break; Break

  IT WAS INITIALLY REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) HAD AN UNFOLDING ISSUE. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REPORTED THAT THE HAPTIC WAS BENT UPON DISCHARGE OF THE AUTOLOAD LENS. ANOTHER LENS WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT HARM. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20511476 ↗
• MalfunctionSep 23, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) FAILED TO DEPLOY CORRECTLY. THE ISSUE WAS NOTED WHEN INSERTING THE LENS INTO THE PATIENT'S LEFT EYE. WHEN THE DOCTOR TRIED TO DEPLOY, THE HAPTIC WAS NOT COMING OUT CORRECTLY. THE LENS DID COME IN CONTACT WITH THE EYE BUT DID NOT COMPLETELY COME OUT OF THE INSERTION DEVICE, WOULD NOT DEPLOY. IT WAS CONFIRMED THAT THE LENS PARTIALLY INSERTED AND WAS IN THE ANTERIOR CHAMBER OF THE EYE. IT WAS MENTIONED THAT SINSKEY HOOK WAS USED; HOWEVER, SINSKEY HOOK DID NOT COME IN CONTACT WITH THE LENS, BUT DID ENTER THE EYE. A NEW JOHNSON & JOHNSON LENS OF THE SAME MODEL AND DIOPTER WAS USED AS A REPLACEMENT THAT DEPLOYED CORRECTLY. NO MEDICAL AND/OR SURGICAL INTERVENTIONS REQUIRED AND NO PATIENT INJURY REPORTED. THE PATIENT WAS SEEN IN OFFICE FOR POST-OP AND NO COMPLICATIONS NOTED. IT WAS INDICATED THAT THE SURGEON DID NOT FEEL ANY RESISTANCE WITH THE DEVICE WHEN ADVANCING THE LENS. THAT BALANCED SALT SOLUTION (BSS) AT ROOM TEMPERATURE WAS USED FOR CARTRIDGE LUBRICATION. THE BSS WAS INTRODUCED INTO THE CARTRIDGE, FROM THE CARTRIDGE CANOPY. THE DWELL TIME WAS THREE (3) MINUTES AND WHEN ADVANCING THE LENS, SMALL ¼ TWIST IS MADE WHICH THE SUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20287207 ↗
• MalfunctionAug 21, 2024Crack; Crack

  IT WAS REPORTED THAT THE INJECTOR TIP OF THE PRELOADED INTRAOCULAR LENS(IOL) WAS BROKEN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018725 ↗