TECNIS IOL ZXR00 (REF ZXR00U0165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 05050474579026), received between Dec 28, 2016 and Mar 10, 2022 — classified as 26 injuries.

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 26 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) NOT CENTERED IN A PATIENT¿S LEFT EYE AND AN ANTERIOR VITRECTOMY WAS PERFORMED. THE LENS WAS REMOVED, AND A NON-JOHNSON & JOHNSON LENS WAS USED AS A REPLACEMENT. NO OTHER INTERVENTIONS WERE INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13727324 ↗
• InjuryMay 28, 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 WAS EXPLANTED/EXCHANGED FROM THE PATIENT'S EYE IN A SECONDARY SURGERY DUE TO POOR RANGE OF VISION, BLURRY VISION, SEVERE GLARE AND HALOS, UNABLE TO REFRACT TO GOOD VISUAL ACUITY (VA), BUT SHOWS POTENTIAL ON PH (PINHOLE). AT EXPLANT, AN INCISION ENLARGEMENT WAS REQUIRED, BUT NO VITRECTOMY OR SUTURES. THE EXPLANTED LENS WAS DISCARDED. VISUAL ACUITY PRE-OPERATIVE: 20/30. VISUAL ACUITY POST-OPERATIVE: 20/70. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 11899440 ↗
• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED HE SEES HALOS GLARES, SHADOWS, LACK OF DEPTH OF PERCEPTION, AND LACK OF CLARITY IN HIS OCULAR DEXTER (RIGHT EYE). HIS VISION HAS BEEN VERY BAD SINCE THE SURGERY AND HIS VISION IS MUCH WORSE AT NIGHT. FOR THE PAST YEAR HE HAS HAD GREAT STRESS AND DISTRESS, BETWEEN SPARKLES, LIGHTS AT NIGHT, HE HAS TROUBLE WITH TRAFFIC LIGHTS, AND HE CAN'T DISTINGUISH THINGS. HIS DOCTOR HAS BEEN AWARE OF THIS SINCE THE BEGINNING, HE FELT THE SYMPTOMS FAIRLY IMMEDIATELY AND NOTIFIED THE DOCTOR OF HIS SYMPTOMS. HE HAS SPOKEN WITH HIS DOCTOR ABOUT SWITCHING TO A MONOFOCAL LENS HOWEVER, WITH COVID-19 A SURGERY DATE HAS NOT BEEN SET. PATIENT ALSO REPORTS IT HAS MADE HIM DIZZY AT TIMES, HE IS VERY DISAPPOINTED AND HE¿S ASTONISHED, AT EVERYTHING THAT HE HAS BEEN GOING THROUGH. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP CONFIRMING NIGHTTIME DRIVING IS AFFECTED AND CONCENTRIC CIRCLES ARE OBSERVED WHEN LOOKING AT BRIGHT LIGHTS AT NIGHT. RIGHT EYE ISSUES WERE NOTICED IMMEDIATELY. PATIENT HAS SEEN THE DOCTOR TWO (02) TIMES, THE FIRST WAS SERVAL MONTHS AGO AND THE SECOND TIME WAS A FEW WEEKS AGO. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE IOL IN THE PATIENT'S OCULAR

  Patient problems: Blurred Vision; Dizziness; Halo; Unspecified Eye / Vision Problem; Visual Disturbances

  MAUDE report 11325665 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT RIGHT EYE. PATIENT REPORTED HAVING EXTREME VISION WHERE IT LOOKS LIKE ALL LIGHTS ARE ON HIGH BEAM, HUGE STARBURSTS NOT JUST CAR LIGHTS BUT ALL LIGHTS. THERE WAS NO STARBURST ISSUE PRIOR TO IMPLANT AND VISION IS NOW WORSE THAN WHEN HE HAD CATARACTS. PATIENT STATES THAT CAR HEADLIGHTS COMING AT HIM ARE SO BIG AND BRIGHT AND IS AFFECTING NIGHT DRIVING, VISION IS EXCELLENT DURING THE DAY. CONCERNED THAT IT IS SO BAD AND CANNOT GET ANSWERS FROM HIS DOCTOR. PATIENT STILL NEEDS TO WEAR GLASSES FOR READING AND SEEING UP CLOSE. NO EXPLANT IS PLANNED, HOWEVER DOCTOR WANTS TO BURN OFF FILM USING LASER PROCEDURE IN FUTURE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT CAPTURES THE ISSUE WITH RIGHT EYE AND A SEPARATE REPORT IS BEING FILED FOR CAPTURING ISSUE IN THE LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 11024200 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CALLED TO REPORT THAT HE HAD A J&J INTRAOCULAR LENS (IOL) IMPLANTED IN HIS LEFT EYE ON (B)(6) 2019. HE IS EXPERIENCING A FLUTTERING EFFECT. IT'S NOT HIS EYE LID IT'S HIS EYEBALL. HIS EYEBALL IS MOVING BACK AND FORTH, CAUSING A KALEIDOSCOPE EFFECT, HE SEES DIFFERENT COLORS. PATIENT SEES IT MORE DURING THE DAY THAN AT NIGHT. PATIENT ALSO HAS TEARING IN THE EYE. THRU FOLLOW-UP THE PATIENT EXPLAINED THAT HE EXPERIENCED FLUTTERING SHORTLY AFTER HIS SURGERY IN NOVEMBER BUT IT COULD HAVE BEEN SOONER. THE PATIENT ALSO EXPLAINED THAT PER HIS DOCTOR, PART OF THE NATURAL LENS MIGHT HAVE BEEN LEFT BEHIND(INSIDE THE EYE). WHICH MIGHT BE CAUSING HIS ISSUES. INITIALLY, THE DOCTOR THOUGHT HIS EYELIDS WERE FLUTTERING SO HE PRESCRIBED DUREZOL. THE PATIENT EXPLAINED TO HIS DOCTOR THAT IT WASN¿T THE EYELID BUT HIS ACTUAL EYE BALL. AT THAT POINT THE DOCTOR STOPPED THE DUREZOL PRESCRIPTION. NOTHING ELSE WAS PRESCRIBED. THE PATIENT UNDERWENT A SECONDARY LASIK SURGERY IN (B)(6). THEY WERE UNABLE TO PROVIDE THE NAME OF THE SURGERY. HOWEVER, THEY REPORTED THAT THEIR VISION IMPROVED IN REGARDS TO THE KALEIDOSCOPE EFFECT AND FLUTTERING. HOWEVER, THE SYMPTOMS ARE MORE FREQUENT THROUGHOUT THE DAY. THE P

  Patient problems: Discomfort; No Code Available; Visual Disturbances

  MAUDE report 10478486 ↗
• InjuryAug 12, 2020Adverse 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 INTOLERABLE GLARE. THE SUSPECT PRODUCT WILL NOT BE RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 10399054 ↗
• InjuryApr 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2020 DUE TO BLURRY VISION, DESCRIBED BY PATIENT AS "FUZZY." PATIENT FEELS LIKE SHE IS LOOKING THROUGH FLUORESCENT LIGHTS. PATIENT COMPLAINS OF DIFFICULTY FOCUSING AND SIGNIFICANT DIFFICULTY DRIVING, ESPECIALLY AT NIGHT AND DIFFICULTY WITH DEPTH PERCEPTION, INCLUDING GOING UP AND DOWN STAIRS. BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) PRIOR TO PRIMARY SURGERY CATARACT EXTRACTION (CE) OD WAS 20/40-2. UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) POST CE OD 20/50 +2. BCDVA POST CE OD WITH MANIFEST REFRACTION 20/20. AT ONE (1) DAY POST IOL EXCHANGE BCDVA OD 20/30-2. VISION HAS IMPROVED SINCE, BUT THE CLINIC HAS NOT BEEN OPEN TO FORMALLY CHECK PATIENT'S VISION. HOWEVER, THE PATIENT HAD A TELEHEALTH APPOINTMENT ON (B)(6) 2020 WITH AN ONLINE VISION CHECK (20/20 UNCORRECTED), THIS IS ONLY AN APPROXIMATE. REPORTEDLY, PATIENT IS FUNCTIONING WELL POST IOL EXCHANGE AND IS SATISFIED WITH POSTOPERATIVE OUTCOME. THE REPLACEMENT LENS IS A NON-TORIC SYMFONY IOL. THE CUSTOMER ALSO INDICATED THAT THE TORIC IOL WAS SENT TO PATHOLOGY AND IS NOT AVAILABLE FOR

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 9966097 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POST-LASIK PATIENT ENDED UP TWO DIOPTERS HYPEROPIC POST-IMPLANT OF A MODEL ZXR00 INTRAOCULAR LENS (IOL) IN THE LEFT EYE. THEREFORE, THE LENS WAS EXPLANTED. THERE WERE NO SUTURES OR VITRECTOMY REQUIRED. THE PATIENT IS REPORTED AS DOING OKAY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 9839348 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD BEEN IMPLANTED WITH LENS IN PATIENT¿S RIGHT EYE ON (B)(6) 2019, INITIALLY IT WAS FINE AND INTRAOCULAR PRESSURE WAS FINE. HOWEVER LATER HER POST OP VISITS LATER INTRAOCULAR PRESSURE RAISED TO 46. THE SURGEON RECOMMENDED HIS ASSOCIATE TO USE A NEEDLE TO RELEASE SOME OF THE PRESSURE, BUT AS THE ASSOCIATE DID NOT WANT TO DO THAT PROCEDURE, COMBIGAN EYE DROPS WERE USED INSTEAD EVERY 15 MINUTES FOUR TIMES. AT NEXT VISIT PATIENT WAS INFORMED THAT LENS HAD RIPPED. THE NEXT DAY OR DAY AFTER THE LENS RIPPED AGAIN. SHE HAS A CONTACT LENS PUT OVER HER EYE FOR THREE DAYS AND THEN REMOVED IT. DOCTOR TOLD HER A CANALOPLASTY WAS CONDUCTED SO SHE WOULD NOT HAVE TO USE GLAUCOMA DROPS, BUT SHE IS STILL USING THE DROPS. HER EYE PRESSURE IS NOW DOWN TO 16. THE PRESSURE DID DROP BUT SHE IS HAVING DIFFICULTY SEEING AND EXPERIENCING PAIN. SHE SAID IT LOOKS LIKE THERE IS LIQUID UNDER THE LENS; LIKE BUBBLES. THE PAIN FEELS LIKE SHE HAS A HARD CONTACT LENS IN HER EYE. SHE CAN¿T SEE OUT OF THE IMPLANTED LENS AND THE OTHER EYE HAS GLAUCOMA. IN ADDITION, SHE SAYS SHE CAN SEE BETTER WHEN SHE WEARS HER PRESCRIPTIVE SUNGLASSES. FURTHERMORE, SHE GOT A SECOND OPINION, AND WAS TOLD SH

  Patient problems: Excessive Tear Production; Intraocular Pressure Increased; Pain

  MAUDE report 9619950 ↗
• InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INTRAOCULAR LENS (IOL) MODEL ZXR00U0165, WITH SERIAL NUMBER (SN) (B)(4), WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2019. AT THE 3-MONTH STUDY VISIT ON (B)(6) 2019, SUBJECT REPORTED THAT SHE WAS MODERATELY BOTHERED BY POOR LIGHT VISION BUT DIDN¿T REPORT ANY ISSUES WITH GLARE OR HALOS AT THAT TIME. AT THE 4-MONTH STUDY VISIT, (B)(6) 2019, SUBJECT STATED ON THE PATIENT-REPORTED VISUAL SYMPTOM QUESTIONNAIRE (PRVSQ) THAT SHE AVOIDS DRIVING AT NIGHT DUE TO GLARE AND HALOS AND SHE CONFIRMED THAT SYMPTOMS ARE DEBILITATING TO DAILY LIVING. DOCTOR INDICATED THAT THE VISUAL SYMPTOMS ARE IOL RELATED. IT WAS REPORTED THE PATIENT EXITED FROM THE STUDY FOLLOWING (B)(6) -2019 STUDY VISIT AND THERE IS NO ADDITIONAL TREATMENT OTHER THAN OBSERVATION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. THIS REPORT IS FOR THE RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 8964287 ↗
• InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXR00 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. AT THE 3-MONTH STUDY VISIT ON (B)(6) 2019, SUBJECT REPORTED THAT SHE WAS MODERATELY BOTHERED BY POOR LIGHT VISION BUT DIDN¿T REPORT ANY ISSUES WITH GLARE OR HALOS AT THAT TIME. AT THE 4-MONTH STUDY VISIT, (B)(6) 2019, SUBJECT STATED ON THE PATIENT-REPORTED VISUAL SYMPTOM QUESTIONNAIRE (PRVSQ) THAT SHE AVOIDS DRIVING AT NIGHT DUE TO GLARE AND HALOS AND SHE CONFIRMED THAT SYMPTOMS ARE DEBILITATING TO DAILY LIVING. DOCTOR INDICATED THAT THE VISUAL SYMPTOMS ARE IOL RELATED. IT WAS REPORTED THE PATIENT EXITED FROM THE STUDY FOLLOWING (B)(6) 2019 STUDY VISIT AND THERE IS NO ADDITIONAL TREATMENT OTHER THAN OBSERVATION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. THIS REPORT IS FOR THE LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 8964267 ↗
• InjuryJun 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE IS HAVING DIFFICULTLY ADAPTING TO HER SYMFONY LENSES IMPLANTED LAST SEPT AND OCTOBER. SHE HAS HALOS/GLARE AND HAS DIFFICULTLY WITH NIGHT DRIVING. SHE CAN'T REALLY SEE THINGS ON THE SIDE OF THE ROAD. SHE IS AN ARTIST AND EVEN THOUGH HER DOCTOR PRESCRIBED ALPHAGAN DROPS, SHE STATES THEY REALLY HAVEN'T HELP TOO MUCH. ONCE SHE ARRIVES AT HER DESTINATION; SHE WORKS UNDER BRIGHT LIGHTS AND THE RX DILATES HER EYES, MAKING IT VERY DIFFICULT FOR HER TO WORK. THIS IS AFFECTING HER DAILY ACTIVITIES. SHE HAS GONE BACK TO HER EYE SURGEON; BUT THE DOCTOR CAN'T HELP HER. DR QUOTED "I HAVE DONE 100,000 OF THESE". THE PATIENT WENT TO ANOTHER DOCTOR IN THE PRACTICE, WHO COULDN'T REALLY HELP AND THEN SHE WENT TO A THIRD DOCTOR OUT OF THE PRACTICE. THAT DOCTOR PRESCRIBED ALPHAGAN. PRIOR TO THE SURGERY, SHE WAS TOLD ALL SHE WOULD NEED IS READERS (OVER THE COUNTER) AND SHE HAS BOUGHT ABOUT 9 PAIRS THAT DON'T REALLY HELP. WHEN SHE WENT TO THE THIRD DOCTOR; HE NOTICED A LITTLE ASTIGMATISM AND ALSO SOME DRY EYE. SHE USES OVER THE COUNTER DROPS. THE EYE SURGEON SHE SAW WAS NEW TO HER AND SHE HAD A LITTLE CATARACT. IT WAS SUGGESTED SHE HAVE LASER DONE BECAUSE NOW THERE

  Patient problems: Halo; No Code Available

  MAUDE report 8746755 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +16.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING ANISOMETROPIA. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. REPORTEDLY LENS WITH SAME MODEL AND HIGHER DIOPTER OF +18.0 WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS DOING FINE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8576398 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 16.5 INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2018. THE IOL WAS EXPLANTED ON (B)(6) 2018 AND REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THE ACCOUNT DOES NOT HAVE IOL TO RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8303778 ↗
• InjuryDec 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REFRACTIVE SURPRISE/HYPEROPIC MISS AFTER THE IMPLANTATION OF MODEL ZXR00 16.5 DIOPTER IOL (INTRAOCULAR LENS) IN HER LEFT EYE (OS). THE PATIENT CONTINUED TO COMPLAIN SO AN EXPLANT WAS PLANNED. THROUGH FOLLOW-UP IT WAS LEARNT THE LENS WAS EXPLANTED AS PLANNED AND EXCHANGED FOR ANOTHER ZXR00 OF A HIGHER DIOPTER (18.0). THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. THE PATIENT WAS REPORTED TO BE STABLE POST EXCHANGE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8198052 ↗
• InjuryDec 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 16.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT COMPLAINED THAT SHE WAS PROMISED TO BE ABLE TO READ WITHOUT GLASSES, HOWEVER, THE PATIENT IS HAVING TO USE 1.25 READING GLASSES. POST-OPERATIVELY AT A FOLLOW UP VISIT ON (B)(6) 2017, THE PATIENT'S VISUAL ACUITY WAS 20/20-2 WITH AN INTRAOCULAR PRESSURE OF 19. AT A FOLLOW UP VISIT ON (B)(6) 2018, THE PATIENT WAS DIAGNOSED WITH MILD EPITHELIAL BASEMENT MEMBRANE DYSTROPHY (EBMD) AND PRESCRIBED MURO 128, 5% EYE DROPS (1 DROP IN EACH EYE FOUR TIMES PER DAY). THE PATIENT'S VISUAL ACUITY IN THE LEFT EYE WAS 20/30-2 WITH AN AUTO REFRACTION OF 0.50 X 0.50 X 50 AND A MANIFEST REFRACTION OF 0.25 SPHERE WITH VISUAL ACUITY 20/25+1. ALSO, THE PATIENT'S NEAR VISION TEST RESULTS WERE J3. AT A FOLLOW UP VISIT ON (B)(6) 2018, THE PATENT'S VISUAL ACUITY IN THE LEFT EYE WAS 20/30+2 WITH A MANIFEST REFRACTION OF -0.75 SPHERE, ADD 1.50 WITH VISUAL ACUITY 20/20. ALSO, THE PATIENT WAS TOLD IT WAS OKAY TO USE OVER THE COUNTER GLASSES +1.00. AT A FOLLOW UP VISIT ON (B)(6) 2018, THE PATIENT'S VISUAL ACUITY IN THE LEFT EYE WAS -0.75 SPHERE WITH VISUAL ACUITY OF 20/20-2 WITH

  Patient problems: No Code Available

  MAUDE report 8172208 ↗
• InjuryDec 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 16.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE THE PATIENT COULD NOT TOLERATE GLARE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING WELL POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8144642 ↗
• InjuryOct 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS COMPLAINING OF SEVERE NIGHT TIME SPIDER WEB POST BILATERAL IMPLANTS OF MODEL ZXR00 TECNIS MULTIFOCAL IOL (INTRAOCULAR LENSES). THE PHYSICIAN HAS BEEN MANAGING THE OCULAR SURFACE. IT WAS NOTED THAT PATIENT'S SYMPTOM WAS FIRST NOTICED ON (B)(6) 2017 DURING HER FINAL VISIT FOR CATARACT SURGERY. ALSO NOTED IS THE PATIENT STATED THAT SHE CANNOT DRIVE AT NIGHT. AS A RESULT, YAG (YTTRIUM ALUMINUM GARNET) LASER WAS PERFORMED ON HER RIGHT EYE (OD) ON (B)(6) 2018; AND SHE WAS PRESCRIBED WITH GLASSES AND WITH CRIZAL, BUT PATIENT STATED THAT IT DID NOT HELP HER WITH DRIVING. THERE WAS NO PATIENT INJURY HOWEVER. THE PRODUCT WILL NOT BE RETURNED AS IT REMAINS IMPLANTED. PRE-OP UNCORRECTED OD 20/150, PRE-OP CORRECTED OD 20/25, POST-OP UNCORRECTED OU (BOTH EYES) 20/20 . NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT PERTAINS TO RIGHT EYE (OD).

  Patient problems: Visual Disturbances

  MAUDE report 7993262 ↗
• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) AND WAS LATER EXPLANTED. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE LENS WAS REPLACED WITH A NON-AMO LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY OR COMPLICATIONS AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7084911 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO HALOS, GLARE, AND BECAUSE THE PATIENT WAS UNHAPPY WITH THEIR NEAR VISION. REPORTEDLY, THESE SYMPTOMS SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THERE WAS AN INCISION ENLARGEMENT MADE. THE LENS WAS REPLACED WITH A PCB00 MODEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7073425 ↗
• InjuryAug 10, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXR00 16.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED DUE TO AN INCORRECT POWER SELECTION. THE LENS WAS SUCCESSFULLY REPLACED WITH ANOTHER ZXR00 LENS OF A HIGHER DIOPTER SIZE (17.5). NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6786964 ↗
• InjuryJul 26, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXR00 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED/EXCHANGED DUE TO THE PHYSICIAN WANTING TO CHANGE FOR A DIFFERENT DIOPTER SIZE. A SAME MODEL LENS WAS USED AS THE REPLACEMENT LENS. THE EXPLANTED LENS WAS NOTED TO BE CUT/DESTROYED. THERE WAS NO INCISION ENLARGEMENT OR PATIENT INJURY.

  Patient problems: No Code Available

  MAUDE report 6743111 ↗
• InjuryMay 8, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXR00 16.5 DIOPTER WAS EXPLANTED DUE TO AN INCORRECT LENS POWER FOR THE PATIENT. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A LOWER DIOPTER AND PATIENT IS NOW DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6553044 ↗
• InjuryFeb 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A NEAR VISION MISS. THE LENS WAS REPLACED WITH THE SAME MODEL LENS OF A HIGHER DIOPTER (18.0). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6342626 ↗
• InjuryJan 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 16.5 DIOPTER WAS EXPLANTED DUE TO UNEXPECTED POSTOP REFRACTION OUTCOME. BEFORE THE SURGERY A 17.5 DIOPTER LENS WAS SELECTED BUT THE ORA (OCULAR RESPONSE ANALYZER) SUGGESTED A 16.5 SIZE LENS. THE PHYSCIAN NOTED THAT EVEN THE 17.5 WOULD NOT HAVE BEEN ENOUGH POWER BECAUSE ON DAY 1 THE PATIENT WAS ABOUT +2 AND THEN AT 6 DAYS THE PATIENT WAS SOMEWHERE BETWEEN + 1.25 AND 1.5 SPHERICAL EQUIVALENT (SE). THE PATIENT'S DISTANCE WAS OKAY BUT THE NEAR WAS POOR. THERE WERE NO COMPLICATIONS REPORTED WITH THE LENS EXCHANGE AND THE SURGEON DOES NOT FEEL THE LENS IS IMPLICATED IN THE REFRACTIVE MISS. DAY 1, AFTER THE LENS EXCHANGE, PATIENT WAS 20/25 AND J5. PATIENT WAS MUCH HAPPIER BUT STILL FAIRLY DILATED. THE PHYSCIAN NOTED THAT THE PATIENT WANTS HER 2ND EYE DONE NEXT WEEK, HOWEVER THE SURGEON PLANS TO HAVE THE PATIENT WAIT A BIT FOR SECOND EYE.

  Patient problems: No Code Available

  MAUDE report 6291696 ↗