TECNIS SIMPLICITY DIB00 (REF DIB00U0215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 05050474731783), received between May 26, 2021 and Sep 14, 2026 — classified as 38 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Break” (30 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the preloaded monofocal intraocular lens (IOL) was implanted in the patient's right eye. During a post-operative examination, the patient experienced negative dysphotopsia, described as feeling as though they were "wearing blinders." The lens was explanted during a secondary surgical procedure and replaced with a non-Johnson & Johnson lens of 21.0 diopter. There were no reports of unplanned incision enlargement, vitrectomy, or sutures being required. The patient was reported to have fully recovered. The directions for use were followed. No additional information was provided.

  Patient problems: Visual Disturbances

  MAUDE report 50755950 ↗
• MalfunctionJul 16, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25842168 ↗
• MalfunctionJun 4, 2026Break; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS OPENED BUT NOT USED IN SURGERY AS IT MALFUNCTIONED WHEN AN ATTEMPT WAS MADE TO INJECT IT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25402953 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A SMALL AREA OF DAMAGE NEAR THE BOTTOM OF THE OPTIC, WHICH WAS OBSERVED FOLLOWING IMPLANTATION. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE LENS WAS LEFT IMPLANTED IN THE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326285 ↗
• MalfunctionMay 12, 2026Material Fragmentation; Mechanical Jam

  IT WAS REPORTED THAT DURING INJECTION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE TRAILING HAPTIC BECAME LODGED ADJACENT TO THE PLUNGER. ATTEMPTS TO ADVANCE THE PLUNGER EXACERBATED THE OBSTRUCTION, WHILE RETRACTION RESULTED IN WITHDRAWAL OF THE ENTIRE IOL. THE SURGEON ATTEMPTED TO DISENGAGE THE HAPTIC USING FORCEPS; HOWEVER, DUE TO SEVERE ENTRAPMENT, THE HAPTIC WAS AMPUTATED, THE IOL WAS REMOVED FROM THE EYE, AND A REPLACEMENT LENS WAS SUCCESSFULLY IMPLANTED DURING THE SAME PROCEDURE. THE PATIENT IS REPORTED TO BE DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25155898 ↗
• InjuryMay 12, 2026Device Difficult to Setup or Prepare; Ejection Problem

  IT WAS REPORTED THAT DURING INSERTION, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE MONOFOCAL INTRAOCULAR LENS (IOL) FROM THE PLUNGER, AND THE LENS FAILED TO FULLY RELEASE FROM THE CARTRIDGE, SUBSEQUENTLY EJECTING ABRUPTLY AND CONTACTING THE PATIENT. THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE, AND A SECOND LENS OF THE SAME MODEL WAS SUCCESSFULLY IMPLANTED WITHOUT FURTHER COMPLICATION. THE PATIENT EXPERIENCED HYPHEMA REQUIRING SUTURES, WHICH WAS SUCCESSFULLY CONTROLLED INTRAOPERATIVELY. AT FOLLOW-UP ON (B)(6) 2026, THE HYPHEMA WAS RESOLVING; HOWEVER, DECREASED VISION (20/400) AND SWELLING WERE NOTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Hyphema; Swelling/ Edema

  MAUDE report 25154118 ↗
• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT A SINGLE PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED FROM MANUFACTURER. THE PRODUCT WAS DISCARDED ACCIDENTALLY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25146325 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED ENDOPHTHALMITIS FOLLOWING IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. THE SURGERY ON (B)(6) 2026 WAS UNCOMPLICATED, WITH SOME INTRAOPERATIVE FINDINGS OF IFIS AND ZONULOPATHY BUT NO IRIS PROLAPSE, NO IRIS EXPANSION DEVICES, AND NO USE OF TRYPAN BLUE; INTRACAMERAL EPISHUGARCAINE WAS USED. THE PATIENT PRESENTED ON (B)(6) 2026 WITH ONE DAY OF DECREASED VISION, AND CLINICAL EXAMINATION WAS CONCERNING FOR ACUTE ENDOPHTHALMITIS; TAP AND INJECT WAS PERFORMED WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS HAEMOLYTICUS, AND THE PATIENT WAS REFERRED FOR FURTHER CARE. MANAGEMENT INCLUDED MULTIPLE TAP AND INJECT PROCEDURES AS WELL AS PARS PLANA VITRECTOMY (PPV), WITH TOPICAL AND INTRAOCULAR TREATMENTS ADMINISTERED AND NO SYSTEMIC OR SUBCONJUNCTIVAL THERAPY REQUIRED. NO INCISION ENLARGEMENT OR SUTURES WERE PERFORMED. THE PATIENT REMAINS IN EARLY POSTOPERATIVE RECOVERY. SYMPTOMS¿ IMPACT ON DAILY ACTIVITIES IS UNKNOWN. ADDITIONALLY, IT WAS LEARNED THAT THERE WERE TWO CASES OCCURRING WITHIN ONE WEEK, BOTH AS FIRST CASES OF THE DAY IN THE SAME OPERATING ROOM; HOWEVER, NO OTHER SIMILAR INCIDENTS OCCURRED ON THE SAME SURGICAL DATE,

  Patient problems: Endophthalmitis

  MAUDE report 25119770 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) IN THE LEFT EYE (OS). FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION, ALTHOUGH DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. THE INTENDED TARGET REFRACTION WAS 20/20. THE PATIENT WAS UNDER-CORRECTED BUT NOT OVER-CORRECTED. IT IS UNKNOWN WHETHER THERE WAS A LOSS OF TWO OR MORE LINES OF BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA). PRE-OPERATIVE REFRACTION AND PRE-OPERATIVE BSCVA WERE UNKNOWN, AS WERE THE POST-OPERATIVE REFRACTION AND POST-OPERATIVE BSCVA. AN INTRAOCULAR LENS EXCHANGE WAS SUBSEQUENTLY PERFORMED, DURING WHICH THE ORIGINAL LENS WAS REPLACED WITH THE SAME MODEL AT A HIGHER DIOPTER VALUE (+22.00 D). NO INCISION ENLARGEMENT OR VITRECTOMY WAS REQUIRED. THE PHYSICIAN NOTED THAT SUTURES ARE USED ONLY WHEN NECESSARY; NONE WERE REQUIRED IN THIS CASE. NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION OUTSIDE THE STANDARD OF CARE WAS NEEDED. THERE WAS NO SURGICAL DELAY, AND DIRECTIONS FOR USE WERE FOLLOWED. IT IS UNKNOWN WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE IOL EXCHANGE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT HAS FULLY RECOVER

  Patient problems: Blurred Vision

  MAUDE report 24624036 ↗
• MalfunctionMar 2, 2026Break

  THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) EXPERIENCED A MALFUNCTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492095 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT¿S EYE DURING THE PROCEDURE BUT WAS SUBSEQUENTLY REMOVED IN THE SAME PROCEDURE DUE TO A RUPTURED CAPSULAR BAG. THE RUPTURE WAS ATTRIBUTED TO THE PATIENT¿S ANATOMY. THE REPLACEMENT LENS WAS A NON¿JOHNSON & JOHNSON PRODUCT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT HAS FULLY RECOVERED. THE DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 24080177 ↗
• MalfunctionJan 12, 2026Material Fragmentation

  DURING PRODUCT HANDLING AND PRIOR TO INSERTION, THE HAPTIC OF THE DIB00 MODEL INTRAOCULAR LENS (IOL) SNAPPED OFF DURING ADVANCEMENT OF THE LENS; THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050140 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE, THE PATIENT EXPERIENCED A REFRACTIVE ERROR. THE LENS WAS SUBSEQUENTLY EXPLANTED IN A SECONDARY SURGERY AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL WITH A +21.0 DIOPTER. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY. NO MEDICATION WAS PRESCRIBED. IT IS UNKNOWN IF THERE WAS ANY DELAY IN THE PROCEDURE. DIRECTIONS FOR USE WERE REPORTED AS NOT FOLLOWED. THE PATIENT'S HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 24012920 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE PATIENT EXPERIENCED DOUBLE VISION AT DISTANCE. THE ISSUE WAS FIRST IDENTIFIED DURING A POST-OPERATIVE EXAMINATION. IT WAS REPORTED THAT THE PATIENT WAS PERMANENTLY IMPAIRED AND UNABLE TO PERFORM ALL DISTANCE ACTIVITIES AS BEFORE SURGERY. PRE-OPERATIVELY, THE PATIENT¿S BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WAS 20/30 AND 20/60 POST-OPERATIVELY. THE LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY AND REPLACED WITH ANOTHER JOHNSON AND JOHNSON LENS OF THE SAME MODEL WITH 20.0 DIOPTER. NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR PROCEDURAL DELAYS OCCURRED, AND NO MEDICATIONS BEYOND THE STANDARD OF CARE WERE PRESCRIBED. POST-OPERATIVE REFRACTION WITH THE REPLACEMENT LENS WAS 20/20, AND THE DOUBLE VISION RESOLVED FOLLOWING THE LENS EXCHANGE. DIRECTIONS FOR USE WERE FOLLOWED. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 23929140 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO OTHER DISORDERS OF THE EYE FOLLOWING CATARACT SURGERY. THE REPLACEMENT LENS WAS ANOTHER JOHNSON AND JOHNSON WITH SAME MODEL AND DIFFERENT DIOPTER (DIB00 AND +18.5). THERE WAS NO UNPLANNED VITRECTOMY OR SUTURES REPORTED. THE DIRECTION FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 23872260 ↗
• InjuryDec 19, 2025Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  IT WAS REPORTED THAT POST IMPLANTATION OF THE INTRAOCULAR LENS (IOL) IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) THE CUSTOMER COMPLAINED OF A LENS POWER ERROR RESULTING IN BLURRY VISION. THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DIB00 MODEL LENS OF 18.5 DIOPTER SIZE. THE FOLLOWING ARE ALL UNKNOWNS: INCISION ENLARGEMENT, MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), IF MEDICAL ATTENTION WAS REQUIRED, SUTURES, VITRECTOMY, AND PATIENT STATUS POST LENS EXCHANGE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 23855339 ↗
• MalfunctionDec 16, 2025Ejection Problem; Ejection Problem

  WHEN THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS PLACED IN THE PATIENT'S OPERATIVE EYE, THE IOL FLIPPED UPSIDE DOWN. THE DOCTOR ATTEMPTED TO REPOSITION THE IOL BUT DETERMINED THAT IT COULD NOT BE ADJUSTED TO THE CORRECT ORIENTATION. THE IOL WAS REMOVED DURING THE SAME PROCEDURE AND REPLACED WITH ANOTHER IOL OF THE SAME TYPE AND DIOPTER. PATIENT PROGNOSIS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823704 ↗
• InjuryDec 9, 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 MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00 WAS FULLY INSERTED INTO THE PATIENT'S LEFT EYE. DURING POST-OPERATIVELY, IT WAS IDENTIFIED THAT THE PATIENT EXPERIENCED POSITIVE DYSPHOTOPSIA. IT IS UNKNOWN IF DAILY ACTIVITIES OF THE PATIENT WERE AFFECTED. THE LENS WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE WITH A NON-JOHNSON & JOHNSON LENS OF +21.0 DIOPTER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTS OF UNPLANNED INCISION ENLARGEMENT, VITRECTOMY AND/OR SUTURES REQUIRED. IT IS UNKNOWN IF MEDICATION OUTSIDE THE STANDARD OF CARE REQUIRED. THE PATIENT HAS FULLY RECOVERED. THE DIRECTION FOR USE WAS FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers

  MAUDE report 23753392 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENTS LEFT EYE DUE TO SURGEON'S PREFERENCE. IT WAS UNKNOWN IF THERE WAS A DELAY IN PROCEDURE, IF AN INCISION ENLARGEMENT, SUTURES, OR A VITRECTOMY WERE REQUIRED OR IF MEDICATION WAS PRESCRIBED. ADDITIONAL INFORMATION WAS PROVIDED AND CLARIFIED THAT THE PATIENTS NEAR AND DISTANCE VISION CONTINUED TO BE BLURRY. THE PATIENT WAS DISPLEASED WITH THE VISION AND HAD BEEN TO THE CLINIC FOR SEVERAL FOLLOW UPS; THEREFORE, IT WAS THE SURGEON¿S DECISION TO EXPLANT THE LENS. THE PATIENT HAD LIGHT ADJUSTABLE LENS (LAL) IMPLANTED AS A REPLACEMENT. AND THE PATIENT IS PLEASED WITH THE OUTCOME. NO OTHER INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENS IMPLANTATION. THIS REPORT IS TO CAPTURE THE PATIENT'S LEFT EYE. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE PATIENT'S RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 23697809 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE (OS) DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 23099828 ↗
• MalfunctionJun 13, 2025Break; Contamination; Break; Contamination

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS NOTICED WITH IRREGULARITY AND EITHER A RIDGE OR HAD SOME SORT OF BLACK MATERIAL ON THE LENS. THE SURGEON HAD TRIED TO CLEAN IT BUT WAS UNABLE TO. THE LENS REMAINS IMPLANTED BECAUSE THE PATIENT WOULD BE AT MORE RISK FOR COMPLICATIONS BY LEAVING THE PATIENT APHAKIC. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207542 ↗
• MalfunctionJun 13, 2025Contamination; Contamination

  IT WAS REPORTED BY THE CUSTOMER THAT STRAY BLUE FIBERS WERE FOUND ON PRELOADED INTRAOCULAR LENS (IOL) IMPLANTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207173 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT THE LEADING HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) WAS BENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748730 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS WAS EXPLANTED DUE TO BLURRY VISION, PERIPHERAL VISION BLOCKAGE AND INABILITY TO ADAPT WHICH WERE OBSERVED APPROXIMATELY EIGHT MONTHS AFTER SURGERY. THE LENS WAS REMOVED DURING A SECONDARY SURGERY AND REPLACED WITH AN UNKNOWN LENS. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, AND NO VITRECTOMY REQUIRED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21472903 ↗
• MalfunctionFeb 11, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF THE INJECTOR OF THE PRELOADED INTRAOCULAR LENS (IOL) HAD BEEN GETTING STUCK, REQUIRING THE USE OF FORCEPS TO REMOVE IT, WHICH RISKS LEAVING THE HAPTIC OUTSIDE OF THE EYE. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT LENS WAS PARTIALLY INSERTED AND HAD TO BE RELEASED FROM INJECTOR WITH A FORCEPS THEN DIALED INTO THE EYE MANUALLY. THERE WAS NO PATIENT INJURY. NO BACK UP LENS WAS USED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21357845 ↗