TECNIS SIMPLICITY DIB00 (REF DIB00U0205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 05050474731769), received between Jun 3, 2021 and Jun 12, 2026 — classified as 23 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 70 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE. THE PATIENT CALLED TO GET FEEDBACK ON THE IOL IMPLANTED. SHE STATED THAT IMMEDIATELY AFTER THE SURGERY SHE EXPERIENCED PAIN THAT PERSISTS TO DATE AND SHE WAS TOLD THAT THIS WAS DUE TO CORNEA INFLAMMATION AND HIGH EYE PRESSURE AFTER SURGERY. SHE WAS PRESCRIBED EYE DROPS WHICH ARE STILL BEING PRESCRIBED AND SHE CONTINUES USING TO DATE. THE NAME OF THE EYE DROPS IS LOTEPREDNOL TOBRAMYCIN. RECENTLY, SHE WAS PRESCRIBED A LOW STEROID. THE PATIENT ASKED IF THE IOL WAS THE CAUSE OF EYE ISSUES, NOTING THAT PRIOR TO SURGERY THERE WERE NO EYE PROBLEMS OR HEALTH ISSUES EXCEPT FOR OCCASIONAL DRY EYE THAT DID NOT REQUIRE TREATMENT. SHE HAD A RAYNER IOL (NON-JNJ PRODUCT) IMPLANTED IN HER LEFT EYE FIRST AND EXPERIENCED NO ISSUES. SHE HAS A JOHNSON AND JOHNSON IOL IN HER RIGHT EYE. THIS HAD BEEN HER STRONG EYE. SHE UNDERWENT A PROCEDURE TO RELEASE EYE PRESSURE ONE MONTH AGO AND WAS PRESCRIBED STEROID DROPS. REPORTEDLY, THE EYE DROPS HAD BEEN DISCONTINUED (B)(6) 2026. THE PATIENT REPORTS NO VISUAL PROBLEMS BUT CANNOT ACCURATELY ASSESS VISION QUALITY DUE TO IRRITATION IN THE RIGHT EYE

  Patient problems: Eye Irritation; Eye Pain; Inflammation; Intraocular Pressure Increased

  MAUDE report 25494324 ↗
• MalfunctionApr 23, 2026Break; Ejection Problem

  IT WAS REPORTED THAT A SINGLE-PIECE, PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IDENTIFIED AS DEFECTIVE DURING THE SURGICAL PROCEDURE. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975149 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SINGLE PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE WITH UNSPECIFIED REASONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24912872 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DUE TO COMPLAINTS OF BLURRY VISION, IRRITATION, AND PAIN THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION IOL, LI61AO 21.5. THERE WERE NO COMPLICATIONS, NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURES DURING THE LENS EXCHANGE PROCEDURE HOWEVER, A PLANNED PARS PLANA VITRECTOMY WAS PERFORMED. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR INVESTIGATION AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Eye Irritation; Pain

  MAUDE report 24624227 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF A SINGLE-PIECE, PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) IN THE PATIENT¿S RIGHT EYE, A TEAR IN THE CAPSULAR BAG WAS OBSERVED. FOLLOWING IDENTIFICATION OF THE TEAR, THE SURGEON ENLARGED THE INCISION AND PERFORMED A VITRECTOMY. THE IMPLANTED LENS WAS THEN REMOVED AND REPLACED WITH A NON JOHNSON & JOHNSON IOL DURING THE SAME SURGICAL SESSION. SUTURES WERE PLACED AS PART OF THE PROCEDURE. NO SURGICAL DELAY WAS REPORTED. NO MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE PRESCRIBED. THE DIRECTIONS FOR USE (DFU) WERE REPORTEDLY FOLLOWED. THE PATIENT¿S DAILY ACTIVITIES WERE NOT IMPACTED POSTOPERATIVELY, AND THE PATIENT ACHIEVED FULL RECOVERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 24527025 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE. AFTER IMPLANTATION THE PATIENT REPORTED BEING UNHAPPY WITH THEIR DISTANCE VISUAL ACUITY WHICH THEY REPORTED AS BLURRY. REPORTEDLY, DISTANCE DAILY ACTIVITIES ARE DIFFICULT FOR THE PATIENT. THE SYMPTOMS LASTED APPROXIMATELY 3 MONTHS. THE CUSTOMER INDICATED THEY FOLLOWED THE DIRECTIONS FOR USE AND REPORTED THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY SUTURES OR DELAY IN THE PROCEDURE. NO MEDICATION WAS NEEDED OUTSIDE OF THE STANDARD OF CARE. THE PATIENT¿S PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (BSCVA) IS +0.50 -0.25 X 103 20/20 AND THEIR POST-OPERATIVE BSCVA IS -1.00 SPHERE 20/15. THE IOL WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A NON JNJ IOL MODEL LAL, +18.5. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 24056958 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). POST-OPERATIVELY, THE PATIENT HAD BLURRY VISION, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A LOWER DIOPTER IOL, REPLACEMENT LENS MODEL INFORMATION WAS NOT PROVIDED. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED, WITH NO SIGNIFICANT IMPACT ON DAILY ACTIVITIES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 23468090 ↗
• MalfunctionOct 16, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT¿S LEFT EYE AFTER THE DOCTOR OBSERVED THAT THE LENS APPEARED SCRATCHED, AS IF SANDPAPER HAD BEEN RUBBED ON IT. THE ISSUE WAS NOT ATTRIBUTED TO USER ERROR. THERE WERE NO REPORTED SYMPTOMS. THE LENS WAS REPLACED WITH ANOTHER JOHNSON & JOHNSON IOL, OF THE SAME MODEL AND DIOPTER. NO MEDICAL OR SURGICAL INTERVENTIONS WERE PERFORMED OR PLANNED. THE PATIENT'S OUTCOME WAS REPORTED AS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23312133 ↗
• MalfunctionOct 15, 2025Break; Break

  THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS WASTED/DAMAGED AND THE EXTENT OF PATIENT CONTACT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302674 ↗
• MalfunctionOct 15, 2025Break; Operating System Becomes Nonfunctional; Break; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT DURING THE PREPARATION OF AN INTRAOCULAR LENS (IOL) FOR INSERTION, THE TECHNICIAN INFORMED THE DOCTOR THAT THE LENS FELT DIFFERENT THAN USUAL. UPON ADVANCING THE LENS INTO THE EYE, AN ISSUE WITH ITS DEPLOYMENT WAS OBSERVED. THE LENS WAS ULTIMATELY INSERTED BUT WAS LATER REMOVED DURING THE SAME PROCEDURE, ALONG WITH THE BACK LENS. ADDITIONAL INFORMATION INDICATES THAT THE HAPTIC WAS DAMAGED, CAUSING IT TO RIP AND THE PLUNGER JUMPING WAS NOTED. THE PATIENT FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280870 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS BROKEN. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088810 ↗
• MalfunctionJun 10, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) DID NOT DEPLOY PROPERLY. THE ISSUE WAS NOTICED AFTER IMPLANTATION AND APPLICATION OF LENS. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE. THE PATIENT WAS TEMPORARILY IMPAIRED. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180545 ↗
• MalfunctionJun 10, 2025Scratched Material; Material Split, Cut or Torn; Scratched Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS TORN AND SCRATCHED BY THE SURGEON. THE ISSUE WAS NOTICED DURING IMPLANTATION /APPLICATION. THE LENS WAS IMPLANTED REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180473 ↗
• MalfunctionJun 10, 2025Failure to Fold; Failure to Fold

  IT WAS REPORTED THAT THE LEADING HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) WAS NOT FOLDED PROPERLY. THE ISSUE WAS NOTICED DURING IMPLANTATION/APPLICATION OF THE LENS. THE LENS WAS IMPLANTED REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180355 ↗
• MalfunctionJun 5, 2025Operating System Becomes Nonfunctional; Ejection Problem; Operating System Becomes Nonfunctional; Ejection Problem

  IT WAS REPORTED THAT THE SIMPLICITY DELIVERY SYSTEM HAD AN ISSUE WHERE THE TRAILING HAPTIC WAS STICKY AND GOT STUCK TO THE PLUNGER, FORCING THE DOCTOR TO USE A SECOND INSTRUMENT. THE LENS WAS SUCCESSFULLY INSERTED INTO THE EYE. THIS REPORT CONCERNS A STICKY PLUNGER, WHICH WAS NOTICED DURING DEVICE ISSUE HANDLING/SETUP/PREP. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22155610 ↗
• MalfunctionMay 6, 2025Break; Break

  THE HAPTIC OF THE DIB00 PRE-LOADED MODEL INTRAOCULAR LENS (IOL) WAS FACING THE INCORRECT DIRECTION. THERE WAS NO PATIENT CONTACT WITH THE IOL. 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 21973126 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). PATIENT REPORTS SHE IS NOT ABLE TO SEE AS SHE ANTICIPATED. SHE CAN SEE WELL UP-CLOSE, FROM EIGHT (08) INCHES AWAY SHE CAN READ THE SMALL PRINT ON THE CARD HOWEVER, SHE CANNOT SEE MORE THAN FIFTY (50) FEET. HER VISION IS FUZZY AND BLURRY. WHEN SHE WAKES UP IN THE MORNING SHE CAN SEE FAR OUT AND CLEARLY BUT AFTER ABOUT TWO (02) HOURS, HER VISION DECREASES AN SHE EXPERIENCES BLURRINESS AND GLARES WHEN IN SUNLIGHT. CURRENTLY THE PATIENT CANNOT DRIVE ON THE FREEWAY, BUT SHE CAN TELL COLORS. SHE HAS DRY EYE AND HER NATURAL LENS REPORTEDLY HAD NO DISTANCE BETWEEN HER RETINA HOWEVER, SHE COULD SEE CLEARLY IN BOTH EYES. THE DOCTOR INDICATED THAT HER NATURAL LENS WAS VERY THICK, WHICH DID NOT ALLOW FOR MOISTURE AROUND THE EYE OR TO RELEASE EYE PRESSURE ISSUES. THE PATIENT WAS HAVING SURGERY TO ADDRESS THIS AND THEY COUPLED IT WITH CATARACT SURGERY. SHE ALSO HAS A HISTORY OF HIGH EYE PRESSURE AND HAD A PHOTOREFRACTIVE KERATECTOMY (PRK) DONE TO CORRECT MYOPIA. SHE NO LONGER WEARS GLASSES AND IS NOT WANTING TO WEAR THEM AGAIN. THE DOCTOR HAS HER TAKING LATANOPROST, SHE IS TAKING STEROIDS TO RELIEVE

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21947672 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE. THE PATIENT IS EXPERIENCING PAIN IN HER LEFT EYE AND BLURRY VISION ON THE OUTER PERIPHERY. THE PATIENT CALLED JOHNSON AND JOHNSON TO ASK IF THERE WAS A RECALL ON THIS LENS AND CLARIFIED THAT SHE IS NOT SAYING IT¿S NECESSARILY THE IMPLANTED LENS. SHE IS A CARRIER OF THE DISORDER CALLED EHLERS-DANLOS SYNDROME (EDS) AND HAS LUPUS. OUT OF CAUTION THE DOCTOR INSERTED A BAUSCH AND LOMB TENSION RING WHEN THE IOL WAS IMPLANTED. THE PATIENT EXPLAINED THAT SHE HAS AN IMPLANT IN BOTH EYES. HER RIGHT EYE IS FINE. HER LEFT EYE IS THE PROBLEM. PRESENTLY HER VISION IN HER LEFT EYE IS 20/200. PRIOR TO HER SURGERY HER VISION IN THE LEFT EYE WAS 20/20. SHE HAD CATARACT IN HER LEFT EYE WHICH GAVE HER HALOS. AFTER SEVERAL MONTHS THEY DECIDED IT WAS TIME TO REMOVE THE CATARACT. THAT¿S WHEN THE JOHNSON AND JOHNSON IOL WAS IMPLANTED. SHE NOTICED HER SYMPTOMS AS SOON AS THE PATCH WAS REMOVED APPROXIMATELY THE NEXT DAY. GLASSES WERE PRESCRIBED CORRECT THE ISSUE BUT NOT COMPLETELY. GLASSES HELP WITH DRIVING DURING THE DAY BUT NOT AT NIGHT. SHE CAN NO LONGER DRIVE AT NIGHT IN UNFAMIL

  Patient problems: Blurred Vision; Eye Pain

  MAUDE report 21914763 ↗
• InjuryApr 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) FLIPPED OVER AFTER IT WAS INSERTED IN THE EYE AND COULD NOT BE FIXED. DURING THE PROCEDURE, THE DOCTOR CUT IT OUT AND HAD TO OPEN AN NEW LENS. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 21906100 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DUE TO COMPLAINTS OF HYPEROPIA, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DIB00 22.0 DIOPTER IOL. DURING THE LENS EXCHANGE PROCEDURE, THERE WAS NO SERIOUS PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY HOWEVER, THE INCISION WAS ENLARGED. PATIENT PROGNOSIS POST-LENS EXCHANGE IN UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 21602392 ↗
• InjuryJan 27, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD PATIENT CONTACT. THE CUSTOMER BELIEVES THE IOL WAS PARTIALLY INSERTED HOWEVER THEY ARE UNCERTAIN. REPORTEDLY, THE IOL WAS WASTED BECAUSE THE CUSTOMER PERFORMED A VITRECTOMY. JOHNSON AND JOHNSON IS PERFORMING FOLLOW-UP TO GET MORE DETAILS REGARDING THE EVENT. TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21247434 ↗
• InjuryJan 15, 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 PATIENT'S RIGHT EYE AS THE PATIENT EXPERIENCED SEVERE DYSPHOTOPSIA AFFECTING PATIENT'S DAILY LIFE. THE LENS WAS FULLY INSERTED AND EXPLANTED IN A SECONDARY PROCEDURE. THE PATIENT SOUGHT MEDICAL ATTENTION AND THAT THE SITUATION HAS RESULTED IN A PERMANENT IMPAIRMENT. THE ISSUE WAS IDENTIFIED DURING POST-OP EXAM. THERE WAS NO PATIENT INJURY. THERE WAS INCISION ENLARGED. THE PATIENT STATUS WAS TEMPORARILY IMPAIRED. THERE WAS DELAY IN PROCEDURE. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE LENS HAD CONTRIBUTED TO DYSPHOTOPSIA. THE LENS WAS REPLACED WITH A NON JNJ LENS THE PATIENT REPORTS THE DYSPHOTOPSIA IS RESOLVED WITH THE REPLACED LENS THE PATIENT FEELS WONDERFUL WITH 20/20 AND VERY HAPPY. THE PATIENT WAS ALLOWED TO WAIT FOR MANY MONTHS TO ADAPT TO THE DYSPHOTOPSIA AND THEN PERFORMED LENS EXCHANGE. NO OTHER INTERVENTION WAS PERFORMED. THE PATIENT HAD SPECIFICALLY MENTIONED SHE WAS BOTHERED BY THE DYSPHOTOPSIA WHILE WORKING ON THE COMPUTER AND DRIVING. THERE WAS NO USE ERROR. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 21162247 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD TO BE REMOVED FROM THE PATIENT'S RIGHT EYE AS THE LENS CAME OUT MANGLED. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE PRELOADED LENS WAS CRACKED AND THERE WAS A DEFECT IN THE PLASTIC SLEEVE. THIS WAS NOT NOTICED AND THE IOL WAS IMPLANTED. THE CRACK WAS CLOSE TO CENTER. THE WOUND WAS ENLARGED AND THE IOL WAS CUT AND REMOVED. A NEW NON PRE-LOADED IOL WAS INSERTED. THE OVD WAS ALLOWED TO ACCLIMATIZE FULLY TO OR TEMPERATURE. THERE WAS NO DELAY IN THE SURGERY BEFORE AN ATTEMPT WAS MADE TO ADVANCE THE LENS. THE LENS HAD MOVED ALL THE WAY OUT, BUT IT WAS HARDER TO PUSH THROUGH THAN USUAL. THERE WAS PRELOADED IOL ERROR. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 21144915 ↗
• MalfunctionJan 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAPTICS WERE STUCK TO THE LENS AND WOULD NOT SPONTANEOUSLY OPEN. THE ISSUE WAS OBSERVED RIGHT AFTER INSERTION INTO THE RIGHT EYE, VIEWED UNDER THE MICROSCOPE. THE SURGEON HAD TO MANUALLY PRY THE HAPTICS WITH THE KUGLEN MANIPULATOR FOR THEM TO UNFOLD. THERE WAS NO POST-OPERATIVE COMPLICATIONS. BALANCED SALT SOLUTION (BSS) WAS USED AT ROOM TEMPERATURE. THERE WERE NO DELAYS IN SURGERY BEFORE AN ATTEMPT WAS MADE TO ADVANCE THE LENS AFTER THE INSERTER WAS PREPPED. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21055904 ↗
• MalfunctionDec 6, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL LENS WAS IMPLANTED BUT WAS FOUND TO HAVE ONLY ONE HAPTIC. ADDITIONAL INFORMATION SUGGESTS THAT THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE WITH ANOTHER JOHNSON & JOHNSON IOL OF THE SAME MODEL AND DIOPTER. THE PATIENT'S VISUAL OUTCOME IS ACCEPTABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20869003 ↗