TECNIS SIMPLICITY DIB00 (REF DIB00U0240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 05050474731844), received between Jun 15, 2021 and Feb 9, 2026 — classified as 11 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Break; Device Difficult to Setup or Prepare; Mechanical Jam; Ejection Problem

  IT WAS REPORTED THAT DURING SURGERY, A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, APPEARED TO BE DEFECTIVE. WHEN THE SURGEON ATTEMPTED TO IMPLANT THE LENS INTO THE PATIENT¿S RIGHT EYE, THE LENS DID NOT DEPLOY PROPERLY. IT ONLY PARTIALLY RELEASED, RESISTANCE WAS NOTED DURING DELIVERY, AND THE LENS BENT AND BECAME STUCK TO THE DELIVERY DEVICE. AS A RESULT, THE LENS WAS NOT IMPLANTED. THE SURGEON REMOVED THE DEVICE WITH THE LENS STILL ATTACHED. ALTHOUGH THE DEVICE AND LENS CONTACTED THE PATIENT¿S EYE, NO HARM WAS OBSERVED. THE DEFECTIVE DEVICE WAS REMOVED FROM THE SURGICAL FIELD, AND A NEW LENS OF THE SAME MODEL AND DIOPTER WAS SUCCESSFULLY IMPLANTED. NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR OTHER ADDITIONAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299604 ↗
• InjuryDec 9, 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 PATIENT'S OPERATIVE EYE DUE TO REFRACTIVE SURPRISE AND DIFFICULTY ADJUSTING TO MONOVISION AFTER IMPLANTATION. PATIENT REQUESTED FOR THE EXPLANT OF THE CURRENT LENS AND ITS REPLACEMENT WITH A NEW LENS TARGETED TO PLANO. ADDITIONAL INFORMATION WAS PROVIDED, AND REPORTED THE EXPLANT WAS PERFORMED. AN UNPLANNED INCISION ENLARGEMENT AND UNPLANNED SUTURES WERE REQUIRED, BUT NO UNPLANNED VITRECTOMY WAS PERFORMED. THERE WAS A DELAY OF 20 MINUTES. THE PATIENT WAS REPORTED TO BE TEMPORARILY IMPAIRED FOLLOWING THE PROCEDURE. THE CUSTOMER STATED THAT NO ADDITIONAL INFORMATION WAS AVAILABLE, CONFIRMED THAT THE PRODUCT WAS NOT AVAILABLE TO BE SHIPPED TO THE TEAM. NO FURTHER INFORMATION WAS RECEIVED.

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

  MAUDE report 23764742 ↗
• InjuryDec 8, 2025Ejection Problem; Physical Resistance/Sticking; Ejection Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING INSERTION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) INTO THE PATIENT'S LEFT EYE, THE HAPTICS BECAME STUCK ON THE OPTIC. WHEN THE LENS WAS FULLY DELIVERED IT FLIPPED AND TORE THE CAPSULAR BAG. THE LENS WAS REMOVED AND A VITRECTOMY WAS PERFORMED. A NON-JOHNSON & JOHNSON 23.5-DIOPTER IOL WAS IMPLANTED AS A REPLACEMENT. A 10-0 NYLON SUTURE WAS USED; THIS IS NOT PART OF THE SURGEON¿S STANDARD PRACTICE AND WAS NOT INTENDED TO PREVENT AN INJURY. ACETAZOLAMIDE (DIAMOX) WAS ADMINISTERED POSTOPERATIVELY IN THE POST-ANESTHESIA CARE UNIT (PACU) PRIOR TO DISCHARGE. THE PATIENT OUTCOME WAS REPORTED AS GOOD. THE ORIGINAL LENS WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 23752963 ↗
• MalfunctionSep 9, 2025Crack; Crack

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (DIB00) EXPERIENCED AN ISSUE IN WHICH THE CARTRIDGE TIPPED OPEN DURING LENS INSERTION. THE CARTRIDGE CAME INTO CONTACT WITH THE PATIENT'S EYE, HOWEVER, NO MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME MODEL AND DIOPTER INTRAOCULAR LENS. THE PATIENT IS REPORTED TO BE DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009828 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO THE PATIENT EXPERIENCING MYOPIC SURPRISE AND AN INABILITY TO TOLERATE MINI MONO VISION. THE PATIENT HAD A PRE-OPERATIVE VISUAL ACUITY OF 20/50 +2 AS OF (B)(6) 2025, AND A POST-OPERATIVE VISUAL ACUITY OF 20/40 ON (B)(6) 2025. AFTER THE EXPLANTATION, ANOTHER JOHNSON & JOHNSON LENS, MODEL DIB00 23.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. IT WAS UNKNOWN IF AN INCISION ENLARGEMENT WAS REQUIRED, HOWEVER, THERE WAS NO SUTURES OR VITRECTOMY REQUIRED. THE PATIENT EXPERIENCED TEMPORARY IMPAIRMENT, BUT DID NOT REQUIRE MEDICAL ATTENTION BEYOND STANDARD CARE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 22391629 ↗
• MalfunctionMar 5, 2025Crack; Crack

  A COMPLAINT WAS REPORTED REGARDING THE DIB00 CARTRIDGE TIP, WHICH CRACKED DURING LENS INSERTION. AS THE LENS IS ADVANCED, THE CARTRIDGE TENDS TO CRACK NEAR THE TIP, RAISING CONCERNS ABOUT POTENTIAL INJURY TO PATIENT. DESPITE THE CRACK, THE LENS WAS SUCCESSFULLY IMPLANTED WITHOUT ANY ADVERSE EFFECTS ON THE PATIENT. IT WAS INDICATED THAT THE SURGEON HAS EXPERIENCED ADDITIONAL SIMILAR INCIDENTS. NO FURTHER INFORMATION WAS PROVIDED. TROUGH FOLLOW UPS, THE ACCOUNT MENTIONED THAT THEY USE BALANCED SALT SOLUTION (BSS) AT ROOM TEMPERATURE, WHICH IS INTRODUCED FROM THE CARTRIDGE CANOPY. THEY DO NOT OPEN THE LENS UNTIL THE END OF PHACOEMULSIFICATION; AT THAT POINT, THEY OPEN THE LENS AND PREPARE IT FOR USE. THE DWELL TIME IS 3 TO 4 MINUTES, AND THE SURGICAL TECHNICIAN PERFORMS THE INITIAL ADVANCEMENT. THE TECHNICIAN BELIEVES THAT THE DOCTOR APPLIES A ¼ TWIST DURING THE ADVANCEMENT PROCESS. IT WAS CONFIRMED THAT THERE HAVE BEEN NO INJURIES IN ANY OF THE CASES, NO INTERVENTIONS HAVE BEEN REQUIRED, AND THE LENSES HAVE BEEN SUCCESSFULLY IMPLANTED AND REMAIN IN PLACE TO DATE. ADDITIONALLY, THE PATIENT'S OUTCOME HAVE BEEN GOOD. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR REPORT PERTAINS TO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21532105 ↗
• MalfunctionFeb 26, 2025Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE FACTORY-SEALED BOX OF THE PRELOADED INTRAOCULAR LENS (IOL) LACKED THE NECESSARY STERILE PEEL PACKS FOR THE INSERTER, IT WAS MISSING. THE ISSUE WAS NOTICED WHILE PREPARING FOR OR CASE AFTER OPENING THE FACTORY SEAL ON BOX. NO OTHER INFORMATION I AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21473930 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE PRELOADED MONOFOCAL LENS WAS EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 20867121 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO SEVERE NEGATIVE DYSPHOTOPSIA AND RESIDUAL ASTIGMATISM. THE IOL WAS REPLACED WITH AN ALCON LENS. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 20234013 ↗
• MalfunctionAug 13, 2024Break; Break

  IT IS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977745 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED INTRAOCULAR LENSES (IOLS) WERE IMPLANTED IN BOTH EYES, THE PATIENT "CAN NO LONGER SEE LONG DISTANCE". THE PATIENT REPORTED THE ISSUE TO THE SURGEON, BUT WAS TOLD THAT THERE WERE NO ISSUES. THE PATIENT HAD REQUESTED TO BE ABLE TO SEE FAR DISTANCE, NOT NEAR VISION. THE PATIENT HAS FUCHS CORNEAL DISEASE. THE SURGEON ADVISED THE PATIENT THAT THE CORNEAL DISEASE MAY HAVE AN EFFECT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO CAPTURE THE PATIENT'S LEFT EYE EVENT. A SEPARATE REPORT WILL BE SUBMITTED TO CAPTURE THE PATIENT'S RIGHT EYE EVENT.

  Patient problems: Blurred Vision; Corneal Epithelial Microcysts

  MAUDE report 19671901 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED INTRAOCULAR LENSES (IOLS) WERE IMPLANTED IN BOTH EYES, THE PATIENT "CAN NO LONGER SEE LONG DISTANCE". THE PATIENT REPORTED THE ISSUE TO THE SURGEON, BUT WAS TOLD THAT THERE WERE NO ISSUES. THE PATIENT HAD REQUESTED TO BE ABLE TO SEE FAR DISTANCE, NOT NEAR VISION. THE PATIENT HAS FUCHS CORNEAL DISEASE. THE SURGEON ADVISED THE PATIENT THAT THE CORNEAL DISEASE MAY HAVE AN EFFECT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO CAPTURE THE PATIENT'S RIGHT EYE EVENT. A SEPARATE REPORT WILL BE SUBMITTED TO CAPTURE THE PATIENT'S LEFT EYE EVENT.

  Patient problems: Blurred Vision; Corneal Epithelial Microcysts

  MAUDE report 19671898 ↗
• MalfunctionApr 22, 2024Material Discolored; Material Discolored

  IT WAS REPORTED THERE WAS A CLOUDINESS ON THE POSTERIOR SIDE OF THE MODEL DIB00 24.0 DIOPTER INTRAOCULAR LENS (IOL). THE IOL WAS EXCHANGED AT THE TIME OF SURGERY FOR ANOTHER DIB00 24.0 DIOPTER IOL THAT WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, AND NO VITRECTOMY. PATIENT STATUS IS PENDING POST-OPERATIVE PERIOD. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19155011 ↗
• MalfunctionApr 18, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN EYHANCE INTRAOCULAR LENS (IOL) WAS FOUND TO BE CRACKED IN CENTER UPON IMPLANTATION/ FULLY INSERTED. LENS REMOVED AND REPLACED. THE LENS APPEARED SCRATCHED IN CENTER AFTER PLACEMENT, EXPLANTED IMMEDIATELY DURING THE SAME PROCEDURE. THE BACK-UP IOL SAME MODEL AND DIOPTER SIZE WAS PUT AS REPLACEMENT. NO CAPSULE TEAR. PATIENT REQUIRED LARGER INCISION AND SUTURES. THE PATIENT POST-OP OUTCOME WAS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 19140645 ↗
• MalfunctionApr 10, 2024Contamination; Contamination

  IT WAS REPORTED THAT A POSTERIOR CAPSULAR OPACIFICATION (PCO) LIKE FILM WAS OBSERVED ON THE ACTUAL LENS. THE LENS WAS LOADED CORRECTLY, BUT AGAIN, IT APPEARS MORE OF THAT CARTRIDGE COATING IS GETTING ON THE OPTIC. THE LENS REMAINS IMPLANTED. NO PATIENT IMPACT POST-OP OR NEGATIVE EFFECTS. IT WAS NOTED THAT IN THE LAST CASE, THEY HYDRATED WITH VISCOELASTIC INSTEAD OF BALANCED SALINE SOLUTION (BSS) AND IT DID NOT HAVE THE RESIDUE AND THE PCO LIKE FILM WAS NOT VISIBLE AT ALL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077145 ↗
• MalfunctionApr 4, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD BY PASSED THE INJECTOR AND MADE CONTACT WITH PATIENTS EYE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047747 ↗
• MalfunctionFeb 1, 2024Delivered as Unsterile Product; Adverse Event Without Identified Device or Use Problem; Delivered as Unsterile Product; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS CONTAMINATED. ADDITIONAL INFORMATION STATES THAT, THIS WAS A SIMPLE CONTAMINATION BEFORE THE IOL WAS EVEN LOADED. THERE WAS NO PATIENT CONTACT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18622760 ↗
• MalfunctionJan 12, 2024Break; Break

  IT WAS REPORTED BY A SURGEON THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE. ADDITIONAL INFORMATION INDICATES THAT THE DOCTOR STATED THE HAPTIC WAS DEFECTIVE. HE DID NOT LIKE THE WAY IT LOOKED AND ASKED FOR ANOTHER LENS TO BE OPENED FOR IMPLANTATION. THE LENS WAS FULLY INSERTED, IN TO THE PATIENT'S RIGHT EYE REMOVED AND REPLACED IN THE SAME PROCEDURE WITH THE SAME MODEL LENS. THE ISSUE WAS IDENTIFIED DURING IMPLANTATION/APPLICATION. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. BSS WAS USED TO PRIME LENS BEFORE IMPLANTATION THAT WAS USED AT THE ROOM TEMPERATURE. BSS WAS INTRODUCED INTO THE CARTRIDGE FROM CARTRIDGE CANOPY WHERE LENS IS ALWAYS PRIMED BEFORE IMPLANTING. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18507972 ↗
• MalfunctionNov 8, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED TORIC MONOFOCAL INTRAOCULAR LENS (IOL) HAD A SCRATCH DOWN THE CENTER OF THE OPTIC. ADDITIONAL INFORMATION REVEALED THAT THE IOL WAS INSERTED AND UNDER THE MICROSCOPE IT WAS VISIBLE THE SCRATCH AT THE CENTER THE IOL, WHICH REQUIRED REMOVAL AND REPLACEMENT. THERE WAS AN INCISION ENLARGEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME MODEL AND DIOPTER BACKUP LENS. NO FURTHER INFORMATION WAS PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097207 ↗
• MalfunctionNov 6, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE LENS SEEMED TO HAVE A PIECE OF LINT OR DUST ON IT UPON IMPLANT INTO THE PATIENT¿S EYE. THE SURGEON INFORMED THAT SHE WAS ABLE TO PHACO THE MATERIAL OFF OF THE LENS, BUT IT SHOULD NOT BE THERE IN THE FIRST PLACE.  THE LENS IS STILL IMPLANTED. THERE WAS NO INJURY, AND SURGICAL AND MEDICAL INTERVENTIONS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18077254 ↗
• MalfunctionAug 8, 2023Break; Operating System Becomes Nonfunctional; Break; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) GOT RIPPED BY THE PLUNGER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17483734 ↗
• MalfunctionMay 19, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DURING THE SAME SURGERY DUE TO A SCRATCH ON THE LENS. THE DOCTOR CONFIRMED THAT THE PATIENT IS DOING WELL AND NO FURTHER ISSUES AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959605 ↗
• MalfunctionMay 9, 2023Break; Break

  THE CUSTOMER REPORTED CENTRAL OPTIC DEFECT ON DELIVERY OF AN INTRAOCULAR LENS (IOL). THE ISSUE WAS NOTICED WHEN INSERTING THE LENS INTO THE PATIENT¿S RIGHT EYE. THE LENS WAS INSERTED AND REMOVED ON THE SAME DAY. ANOTHER LENS OF THE SAME MODEL AND DIOPTER WAS USED AS A REPLACEMENT. NO MEDICAL OR UNPLANNED SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT WAS REPORTED TO BE DOING FINE POST-OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16892911 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) IN CAUSING THE PATIENT TO EXPERIENCE BLURRY VISION WHILE WATCHING TELEVISION OR LOOKING AT HER DOG. SHE¿S SCARED TO GET IN THE TUB DUE TO HER BLURRY VISION. ADDITIONALLY, THE SUNLIGHT HURTS HER EYES. SHE¿S ALSO EXPERIENCING HEADACHES, NAUSEATED AND SEIZURES. THE SEIZURES OCCUR BOTH INSIDE AND OUTSIDE THE HOUSE. PATIENT STATED SHE NEVER HAD SEIZURES PRIOR TO THE IMPLANTS. WHEN THE IOLS WERE INITIALLY IMPLANTED HER VISION WAS FINE. THE SYMPTOMS STARTED IN BOTH EYES ABOUT 4 MONTHS AGO. THIS REPORT IS FOR THE LEFT EYE. THE PATIENT FEELS THE SYMPTOMS ARE DEBILITATING AS SHE CAN NO LONGER GO OUTSIDE TO HER GARDEN LIKE SHE USED TO DO. REPORTEDLY, HER SYMPTOMS ARE THE SAME IN BOTH EYES BUT WORSE IN THE RIGHT EYE. BOTH EYES WERE DONE ONE MONTH APART BUT COULD NOT REMEMBER WHICH EYE WAS DONE FIRST. SHE¿S UNDER A LOT OF STRESS BECAUSE SHE IS GOING THROUGH A DIVORCE AT 64 YEARS OLD. HOWEVER, SHE BELIEVES HER SYMPTOMS ARE DUE TO THE IOL IMPLANTS. THE PATIENT PROVIDED A SERIAL NUMBER FOR HER RIGHT EYE THAT DID NOT ALIGN WITH A JOHNSON AND JOHNSON(JNJ) PRODUCT. HOWEVER SHE REPORTED BOTH EYES HAVE A JNJ IOL. IN ABUNDANCE OF CAUTION JNJ WILL SUBMIT A

  Patient problems: Blurred Vision; Convulsion/Seizure; Headache; Nausea; Visual Disturbances

  MAUDE report 16710626 ↗
• MalfunctionFeb 15, 2023Scratched Material; Scratched Material

  AFTER THE DIB00 INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S OCULAR DEXTER (RIGHT EYE) IT WAS REPORTED THERE WAS A LARGE CENTRAL SCRATCH. AN ATTEMPT WAS MADE TO BUFF THE IOL, THE SCRATCH EXTENDED TO THE INNER PORTIONS OF THE LENS. THE IOL WAS CUT OUT AND A NEW LENS WITH THE SAME MODEL AND DIOPTER SIZE WAS INSERTED. THE IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. DISTRIBUTOR REPORTING FORM INDICATED INCISION ENLARGEMENT OCCURRED. PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 16383433 ↗