TECNIS IOL ZXR00 (REF ZXR00U0215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 05050474579125), received between Dec 21, 2016 and May 3, 2024 — classified as 88 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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 18, 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.

• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON-PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE DUE TO THE PATIENT BEING UNABLE TO ADAPT. THE SYMPTOMS PERSISTED FOR 133 DAYS. THE ISSUE WAS FIRST IDENTIFIED DURING A POST-OPERATIVE EXAMINATION. NO UNPLANNED VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES WERE REQUIRED. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (ZCB00, 21.0 DIOPTER). THE PATIENT HAS FULLY RECOVERED. DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 19244396 ↗
• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON WILL EXPLANT THE NON-PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) DUE TO BLURRY VISION AND GLARE/HALOS/RINGS. ADDITIONAL INFORMATION WAS RECIEVED AND IT WAS LEARNT THAT EXPLANT WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 18580828 ↗
• InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON-PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME MODEL, +20.0 DIOPTER). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 18422399 ↗
• InjuryNov 29, 2023Adverse 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 RIGHT EYE DUE TO VISUALLY DISABLING GLARE. THE SYMPTOM WAS DEBILITATING TO THE PATIENT. THE GLARE WAS REPORTED SHORTLY AFTER SURGERY. THERE WAS NO CAPSULE TEAR, NO UNPLANNED VITRECTOMY OR SUTURES. THE REPLACEMENT LENS IS A JNJ LENS BUT A DIFFERENT MODEL AND DIOPTER, ZA9003 23.0 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 18233658 ↗
• InjuryJul 10, 2023Material Discolored; Material Discolored

  IT WAS REPORTED THAT A PATIENT IS NOT HAPPY WITH VISION IN RIGHT EYE (OD). VISION CANNOT GET THEM TO 20/20 OR 20/25 IN THAT EYE AND THAT THE INTRAOCULAR LENS (IOL) HAS A HAZY SURFACE TO IT. THE DOCTOR IS PLANNING IN THE COMING WEEKS TO EXCHANGE OD WITH A NEW SYMFONY OR POSSIBLY A MONOFOCAL. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE IOL WAS EXPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 17294401 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THROUGH FOLLOW-UP WITH THE DOCTOR, IT WAS LEARNED THAT PATIENT ORIGINALLY HAD CATARACT SURGERY IN (B)(6) 2020 WITH FEMTOSECOND LASER. PATIENT HAD LASER YTTRIUM ALUMINUM GARNET (YAG) DONE IN (B)(6) 2020 ON THE OD. IT WAS ALSO REPORTED THAT THE PATIENT HAD THE YAG PROCEDURE DONE ON (B)(6) 2022 OD WHICH WAS PERFORMED BECAUSE THE PATIENT COMPLAINED ON (B)(6) 2022. IT IS UNCLEAR WHICH IS THE CORRECT DATE OF THE YAG PROCEDURE OR IF IT WAS DONE TWICE. THE DATE SYMPTOMS WERE FIRST NOTED WAS (B)(6) 2022. THE DOCTOR¿S OFFICE REPORTED THAT THE PATIENT DOES NOT HAVE ANY ISSUES OR COMPLAINTS ABOUT THE OD. THE PATIENT IS ABLE TO SEE WITH CORRECTION. THE PATIENT¿S PRE-OPERATIVE VISUAL ACUITY (VA) ON (B)(6) 2020, WAS 20/50 OD. THE PATIENT POST-OPERATIVE VA ON (B)(6) 2020 WAS 20/30 OD. AT THE MOST RECENT EXAM ON (B)(6) 2023, THE PATIENT¿S UNCORRECTED VA WAS OD 20/30 AND CORRECTED VA WAS OD 20/25. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Discomfort

  MAUDE report 16400671 ↗
• MalfunctionMay 31, 2022Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS DAMAGED AND NOT IMPLANTED. ANOTHER JOHNSON & JOHNSON LENS WITH THE SAME MODEL AND DIOPTER SIZE WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14553651 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INTRAOCULAR LENSES (IOLS) IMPLANTED SEVERAL YEARS AGO IN BOTH EYES. THE PATIENT RETURNED TO THE DOCTOR SIX MONTHS AFTER THE INITIAL SURGERY WITH A COMPLAINT THAT THE VISION WAS NOT GOOD. THE DOCTOR INFORMED THE PATIENT THAT THERE WAS A "GROWTH" AND THE DOCTOR "CUT THE GROWTH OUT WITH A LASER." THE PATIENT WAS TOLD BY THE DOCTOR THAT GLASSES WOULD BE NEEDED TO SEE. THE PATIENT WAS TOLD THAT AN IOL EXCHANGE WAS NOT POSSIBLE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE RIGHT EYE EVENT. A SEPARATE REPORT IS BEING FILED FOR THE LEFT EYE EVENT.

  Patient problems: Blurred Vision; Insufficient Information

  MAUDE report 14247007 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE) AND EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF POOR VISION, GLARE WITH ASTHENOPIA, AND GLARE. THE EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. IT WAS ALSO REPORTED DAILY ACTIVITIES ARE SIGNIFICANTLY AFFECTED. THE WAS NO UNPLANNED VITRECTOMY. PATIENT STATUS WAS REPORTED AS TEMPORARILY IMPAIRED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO COMPLICATIONS, SUCH AS CAPSULAR TEAR, NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, AND NO UNPLANNED SUTURE(S). REPORTED POOR VISION WAS CLARIFIED AS: LIGHTS TOO BRIGHT, HAVE TO HAVE LIGHT BEHIND TO READ, HEADACHES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Headache; Insufficient Information; Visual Disturbances

  MAUDE report 12472422 ↗
• MalfunctionAug 26, 2021Difficult to Fold, Unfold or Collapse; Physical Resistance/Sticking; Difficult to Fold, Unfold or Collapse; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) FOLDED OVER WHEN IT WAS INSERTED INTO THE PATIENT'S RIGHT EYE. THE DOCTOR WAS UNABLE TO UNFOLD IT AS HAPTICS WERE DESCRIBED AS PRAYING. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER. THERE WAS NO INJURY TO THE PATIENT AND THERE WERE NO COMPLICATIONS POST-OPERATIVELY. PATIENT'S VITALS WERE REPORTEDLY STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375541 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE), AND AS SOON AS THE PATIENT OPENED HER EYES SHE SAW A SORT OF SHADOW ON THE IOL. SHE HAS SEEN FIVE (05) DIFFERENT OPHTHALMOLOGISTS AND THEY HAVE ALL SAID THE SURGERY WAS PERFECT. HER VISION IS QUITE GOOD, 20-20, BUT, SHE IS MISERABLE DUE TO NEGATIVE DYSPHOTOPSIA. HER EYE FEELS HEAVY AND AS IF THERE¿S SOMETHING IN IT ALL THE TIME; SUNGLASSES HELP. PATIENT WAS TOLD THAT THERE ARE A SMALL PERCENTAGE OF PEOPLE WHO GET THIS BAD SIDE EFFECT. PATIENT'S VISION HAS ALWAYS BEEN EXCELLENT AND SHE NEVER WORE GLASSES, EXCEPT FOR READING. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING HER VISION IS GOOD, IT¿S THE SENSATIONS/SYMPTOMS IN HER EYE THAT ARE DEBILITATING. AS SOON AS SHE OPENED HER EYES AFTER SURGERY SHE NOTED THERE WAS STICKING IN HER EYE AND THERE WAS A SHADOW. ALL FIVE (05) DOCTORS CONFIRMED NEGATIVE DYSPHOTOPSIA DIAGNOSIS AND STATED THIS MIGHT GO AWAY IN TIME. PATIENT WAS GIVEN DROPS FOR DRY EYE TO LESSEN THE PROBLEM AND WAS TOLD TO WEAR GLASSES. WEARING GLASSES DOES HELP AND SHE FILLED A PRESCRIPTION FOR NO CORRECTION GLASSES. THEY DO HELP SOMEWHAT BUT AFTER AN HO

  Patient problems: Foreign Body Sensation in Eye; Visual Disturbances

  MAUDE report 12112591 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO HALO/GLARE, VISUAL DISTURBANCE. THE IOL WAS REPLACED WITH A DIFFERENT MODEL, ZA9003 WITH A HIGHER DIOPTER, 22.0. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11898988 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXR00 INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO PATIENT EXPERIENCING ANISOMETROPIA AFTER IMPLANTATION OF THE LENS. THE REPLACEMENT LENS USED IS A SAME MODEL DIFFERENT DIOPTER, 19.5. THIS EVENT WAS OBSERVED DURING POST OPERATIVE EXAMINATION. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 11532641 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL STUDY SUBJECT WAS IMPLANTED BILATERAL INTRAOCULAR LENSES (IOLS) AND COMPLETED THE PATIENT-REPORTED VISUAL SYMPTOM QUESTIONNAIRE AT THE 1 MONTH VISIT AND REPORTED EXTREMELY BOTHERED BY HALOS, NIGHT DRIVING IS DIFFICULT; EXTREMELY BOTHERED BY SCATTERED LIGHT, DRIVING; VERY BOTHERED BY POOR LOW LIGHT VISION, READING IN LOW LIGHT. VISUAL ACUITY- 20/25 RIGHT EYE (OD); 20/20 LEFT EYE (OS). SUBJECT REPORTS SYMPTOMS AS DEBILITATING. HOWEVER, NO INTERVENTION PLANNED AT THIS TIME. PRE-OPERATIVE BCDVA: 20/30 RIGHT EYE, 20/20 LEFT EYE IT WAS LEARNED THAT THE SUBJECT RETURNED FOR A 6-MONTH VISIT. MONOCULAR UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA): 20/40 OD, 20/20 OS; BCDVA: 20/30 OD, 20/20 OS. THE PATIENT REPORTED VISUAL SYMPTOM COMPLAINTS FOR BOTH EYES (OU) ON THE QUESTIONNAIRE: SUBJECT REPORTED BEING EXTREMELY BOTHERED BY HALOS, WORRY A LOT WHEN DRIVING AT NIGHT THAT THE HALOS COVER UP A CAR AHEAD OF ME WHEN ANOTHER CAR IS APPROACHING; EXTREMELY BOTHERED BY STARBURSTS- THE PATIENT FEELS THAT IT IS MORE DIFFICULTY TO DRIVE AT NIGHT THAN BEFORE, HOWEVER CAN STILL DRIVE; EXTREMELY BOTHERED BY SENSITIVITY TO LIGHT- THE PATIENT SQUINTS WITHOUT SUNGLASSES; AND EXTR

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11387230 ↗
• InjuryJan 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE AS PATIENT COULD NOT DRIVE AT NIGHT DUE TO THE HALOS AND GLARES. PRE-OP VISUAL ACUITY WAS 20/25. A DIFFERENT MODEL ZCB00, LOWER DIOPTER POWER 20.5 WAS IMPLANTED INSTEAD. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11206490 ↗
• InjuryJan 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FORM THE PATIENT'S RIGHT EYE DUE TO PATIENT NOT ABLE TO DRIVE AT NIGHT BECAUSE OF HALOS AND GLARES. IOL WAS REPLACED WITH A DIFFERENT MODEL, ZCB00, LOWER DIOPTER POWER, 24.0 LENS. IT WAS NOTED THAT PRE-OP VISUAL ACUITY WAS 20/30. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11206414 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENTS RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO BLURRINESS. THERE WAS NO PATIENT INJURY AND NO MEDICAL/SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE REQUIRED. THE REPLACEMENT LENS USED IS A NON-JOHNSON & JOHNSON VISION LENS. THE PATIENT WAS ALRIGHT AT THE TIME OF DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 11181614 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT EXPERIENCING HALOS, GLARES AND VISUAL DISTURBANCE. THERE WAS NO INCISION ENLARGEMENT. PATIENT HAS RECOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 10365291 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT¿S LEFT EYE IN SECONDARY SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY, NO SUTURES AND NO VITRECTOMY REQUITED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS WAS EXPLANTED BECAUSE THE PATIENT WAS UNABLE TO ACHIEVE GOOD QUALITY NEAR VISION WITH THE LENS. REPORTEDLY LENS WITH A DIFFERENT MODEL, ZLB00 AND HIGHER DIOPTER OF +22.5 WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT IS STABLE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10198760 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS BEEN HAVING VISUAL ISSUES FROM DAY 1 RIGHT AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN HIS RIGHT EYE. THE PATIENT REPORTED NOT BEING ABLE TO SEE CLEAR, HAD DOUBLE VISION WHEN READING AND WITH DISTANCE VISION, AND EXPERIENCED GLARE ISSUES. THE SURGEON PERFORMED LASIK IN (B)(6) 2019 TO HELP IMPROVE WITH VISION, HOWEVER, THE PATIENT REPORTED THERE WAS NO IMPROVEMENT WITH HIS VISION. IN (B)(6) 2019, THE PATIENT WAS GIVEN PRESCRIPTION GLASSES AND STILL HAD NO IMPROVEMENT WITH HIS VISION. THEREFORE, THE LENS WAS EXPLANTED AND REPLACED USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. THE PATIENT HAS RECOVERED AND IS HAPPY WITH HIS VISION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10130846 ↗
• InjuryMay 13, 2020Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO ANTERIOR DEPOSITS ON LENS. IT WAS LATER CLARIFIED THAT UNDER THE MICROSCOPE THE LENS HAD TINY IMPERFECTIONS WHICH THEY ARE UNSURE OF THE CAUSE. A DIFFERENT LENS MODEL AND DIOPTER (ZXT150, 19.5 DIOPTER) WAS USED AS REPLACEMENT FOR THE PATIENT. THERE WAS NO INCISION ENLARGEMENT REQUIRED AND NO OTHER SURGICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10050248 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT LEFT EYE DUE TO SPECIFIC VISUAL ISSUES OF GLARE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9912429 ↗
• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING HALOS POST INTRAOCULAR LENS (IOL) IMPLANTS IN (B)(6) 2019 IN BOTH EYES. REPORTEDLY THE CATARACT WAS PERFORMED 1-2 YEARS AFTER HAVING LASIK TO REMOVE BUMP ON HER EYE, TO SMOOTH THE CORNEA. SURGEON HAD TO HAVE FLUID DRAINED FROM BOTH EYES ABOUT 6 WEEKS AGO. SURGEON STATES THAT PATIENT NOW HAS DRY EYE, REQUIRING LIPIFLOW TREATMENTS. PLUGS WERE PUT IN HER TEAR DUCTS TO KEEP FLUID IN HER EYES INSTEAD OF FLOWING OUT. SURGEON PRESCRIBED HER GLASSES FOR GLARE, BUT SHE STILL CAN¿T SEE WHEN WATCHING TV. PATIENT STATED THAT SHE HAD AN INCIDENT WHERE SHE THOUGHT SHE NEEDED TO GO TO THE EMERGENCY ROOM BUT COULD NOT DRIVE HERSELF BECAUSE IT WAS TOO HARD TO SEE BETWEEN LIGHT AND DARK WITH THE GIANT HALOS AROUND LIGHT SOURCES. SHE IS WANTING TO SEE IF THE DRY EYE IS CAUSING A PROBLEM WITH THE LENS. HER SURGEON IS SAYING THIS IS THE CASE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT SHE IS NOT ABLE TO DRIVE AT NIGHT, TV GLOWS BADLY, HAS LOT OF ISSUE WITH LED LIGHT. DOCTOR DID PROVIDE HER COMPLIMENTARY ANTI-GLARE GLASSES WHICH HELPED HER FOR SOME TIME. HOWEVER, SHE IS STILL HAVING A LOT OF GLARE AT NIGHT. DOCTOR DID TALK ABOUT OPTION OF LEN

  Patient problems: Halo; No Code Available

  MAUDE report 9804091 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXR00 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER-OD(RIGHT EYE) ON (B)(6) 2018. PATIENT REPORTS COMPLAINTS OF POOR DISTANCE VISION AND FEELS VISION IS WORSE THAN BEFORE SURGERY. (B)(6) 2019 OD POST-OP REFRACTION WAS REPORTED AS -75+50@20. PATIENT HAS DRY EYE BUT IS USING PUNCTUM PLUGS, AND HAS HAD CORNEAL TREATMENT WITHOUT IMPROVEMENT. PATIENT ALSO HAS AN INSIGNIFICANT EPIRETINAL MEMBRANE (ERM) IN OD. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION STATING THERE WERE NO DRY EYE ISSUES. WHEN THE PATIENT WAS NOT SATISFIED WITH VISION, THE DOCTOR TREATED FOR DRY EYE IN THE ABSENCE OF CLINICAL SIGNS OR SYMPTOMS WITH LUBRICANT EYE DROPS AND ANTI-INFLAMMATORY EYE DROPS AND PUNCTUAL PLUGS WITH NO IMPROVEMENT IN SUBJECTIVE VISUAL QUALITY PER PATIENT. ALSO COMPLETED LASER CAPSULOTOMY BOTH EYES FOR MINIMAL POSTERIOR CAPSULAR OPACIFICATION (PCO). NO IMPROVEMENT IN SUBJECTIVE VISUAL QUALITY PER PATIENT. THIS REPORT CAPTURES THE IOL IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). A SEPARATE REPORT WILL BE FILED FOR THE PATIENT'S OCULAR SINISTER-OS (LEFT EYE). NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL

  Patient problems: Blurred Vision; Dry Eye(s); No Code Available

  MAUDE report 9760777 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 IOL 21.5 DIOPTER WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO THE PATIENT WAS UNHAPPY WITH THEIR VISION RESULTS. IT WAS REPLACED WITH A NONE JNJ LENS. REPORTEDLY, THERE WAS NO INCISION ENLARGEMENT AND THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9741211 ↗