TECNIS IOL ZXR00 (REF ZXR00U0185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 05050474579064), received between Nov 11, 2016 and Oct 2, 2023 — classified as 57 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (7 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 60 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE NON-PRELOADED EXTENDED RANGE OF VISION INTRAOCULAR LENSES (IOLS) WERE IMPLANTED IN BOTH EYES, THE PATIENT INITIALLY COULD SEE WELL, BUT SOMETIME IN (B)(6) 2023 THE PATIENT STOPPED BEING ABLE TO SEE CLOSE UP. THE PATIENT REPORTED THAT THE CLOSE UP VISION IS BLURRED, EVEN WHEN NOT LOOKING AT ANYTHING. AFTER PUTTING ON GLASSES, THE PATIENT CAN SEE UP CLOSE AGAIN. THE PATIENT FEELS LIKE SOMETHING IS IN THE EYES AND IT FEELS LIKE THE EYES ARE FUZZY WHEN CLOSED, LIKE ¿THEY ARE GOING OVER SOMETHING¿. THE PATIENT REPORTED THAT THE SYMPTOMS DO NOT SIGNIFICANTLY INTERFERE WITH DAILY ACTIVITIES. NO MEDICAL OR SURGICAL INTERVENTION HAS BEEN DONE FOR EITHER EYE AND NOTHING IS PLANNED AT THIS TIME. THE PATIENT HAS AN APPOINTMENT SCHEDULED FOR (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON JUL 26, 2023 REPORTING THAT THE PATIENT VISITED THE DOCTOR ON (B)(6) 2023 AND WAS ADVISED THAT THE LENSES ARE DOING FINE AND ARE DOING ¿WHAT THEY ARE SUPPOSED TO BE DOING¿. THE PATIENT WAS TOLD THE EYES ARE REALLY DRY AND THAT THE DOCTOR WAS GOING TO BE PERFORMING A ¿LASER TREATMENT¿ ON EACH EYE. THE DATES OF THE SCHEDULED LASER PROCEDURES ARE (B)(6) 2023. AD

  Patient problems: Blurred Vision; Dry Eye(s); Foreign Body Sensation in Eye

  MAUDE report 17854223 ↗
• InjuryAug 3, 2022Material Fragmentation; Device Dislodged or Dislocated; Material Fragmentation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REPOSITIONED DUE TO PATIENT WAS UNHAPPY WITH VISION IN THE LEFT EYE (OS). VISION HAD DECEASED FOR DISTANCE AND NEAR. THERE WAS NO SPECIFIC ONSET DATE NOTED IN THE CHART. DURING EVALUATION, THE LENS HAD DISLOCATED AND ONE HAPTIC WAS IN THE BAG WHILE THE OTHER HAPTIC WAS IN THE SULCUS AND LENS DECENTERED. THE LENS WAS REPOSITIONED ON (B)(6) 2021. THERE WAS NO PATIENT INJURY. THERE WERE NO VITRECTOMY PERFORMED, NO INCISION ENLARGEMENT REQUIRED, AND NO OTHER MEDICAL OR SURGICAL INTERVENTION REPORTED. THE PATIENT IS DOING GOOD POST-OPERATIVELY. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 15154607 ↗
• InjuryJul 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL), MODEL ZXR00 OF 18.5 DIOPTER POWER, WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). THE IOL WAS EXPLANTED IN A SEPARATE SURGICAL PROCEDURE DUE TO IOL DISLOCATION. LENS MODEL ZXR00 OF 19.5 DIOPTER POWER WAS PLACED AS THE REPLACEMENT IOL. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY. PATIENT OUTCOME WAS REPORTED AS FINE. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 15060350 ↗
• InjuryApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT (OS) EYE DUE TO DYSPHOTOPSIA AND STARBURSTS AT NIGHT. ANOTHER JOHNSON & JOHNSON ZA9003 LENS (DIFFERENT MODEL AND 20.0 DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT OUTCOME POST SURGERY IS UNKNOWN. THE SUSPECT LENS HAS BEEN DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Visual Disturbances

  MAUDE report 14120413 ↗
• InjuryApr 8, 2022Adverse 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 THE PATIENT'S LEFT (OS) EYE DUE TO DYSPHOTOPSIA AND SEEING STARBURSTS AT NIGHT. A JOHNSON AND JOHNSON MONOFOCAL IOL, MODEL ZA9003/20.0 DIOPTER, WAS PLACED AS THE REPLACEMENT LENS. THE EXTRACTED LENS HAS BEEN DISCARDED. THE PATIENT OUTCOME POST SURGERY IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Visual Disturbances

  MAUDE report 14059051 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED BILATERAL IMPLANTS WITH THE SYMPHONY INTRAOCULAR LENSES (IOLS). THE RIGHT EYE WAS DONE 5 WEEKS AGO AND THE LEFT EYE 3 WEEKS AGO. REPORTEDLY THE PATIENT HAS AS SHE WANTED. SHE WAS J3 AT 18 INCHES BUT SHE WANTS CLOSER. THE SURGEON EXPLANTED THE LENS FROM THE PATIENT'S RIGHT (OD) EYE AND REPLACED IT WITH A SYNERGY IOL, DFR 18.5 DIOPTER. THE PROCEDURE WENT FINE AND THE PATIENT WILL BE SEEN BY HIM FOR A FOLLOW UP VISIT. THE DOCTOR IS WAITING UNTIL THEN TO GOOD DISTANCE AND INTERMEDIATE. THE PATIENT COMPLAINS THAT SHE DOES NOT HAVE AS MUCH NEAR VISION MAKE ANY INITIAL DETERMINATION OF HOW THE NEW LENS IS WORKING OUT. THE EXPLANTED LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT REPRESENTS THE RIGHT (OD) EYE. THE LENS IN THE LEFT EYE REMAINS IMPLANTED.

  Patient problems: Visual Impairment

  MAUDE report 12517107 ↗
• InjuryJul 13, 2021Adverse 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'S EYE DUE TO PATIENT HAVING NO NEAR VISION AND VERY POOR INTERMEDIATE VISION DURING THE POST OPERATIVE VISIT. THE CURRENT MANIFEST REFRACTION WAS +0.75 -0.50X180 20/20, AND A +0.75 TRIAL LENS INCREASED BOTH DISTANCE VISION AND NEAR VISION. THE PATIENT HAD A POST-OPERATIVE VISUAL ACUITY 20/20-1 12 POINT NEAR VISUAL ACUITY. THE INCISION WAS ENLARGED TO REMOVE THE ORIGINAL LENS FROM THE EYE AND A SUTURE WAS PLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 12163268 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 MODEL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO PATIENT EXPERIENCING BLURRY DISTANCE VISION, STARBURST, AND GLARES. AT EXPLANT THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES WERE REQUIRED. THE REPLACEMENT LENS WAS A DIFFERENT MODEL, DCB00 AND DIOPTER 19.0. PATIENT WAS FINE AND DOING WELL POST-EXCHANGE. ADDITIONAL INFORMATION RECEIVED STATED THAT ONSET OF SYMPTOMS, STARBURST PATTERNS, PAIN, DISCOMFORT, AND FLOATERS WERE SINCE THE INITIAL SURGERY. THE SUSPECT PRODUCT WAS DISCARDED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision; Eye Pain; Flashers; Visual Disturbances; Vitreous Floaters

  MAUDE report 11971532 ↗
• InjuryMar 31, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A ZXR00 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO POWER MISS OF -0.50 AND THE PATIENT IS UNHAPPY. ADDITIONAL INFORMATION RECEIVED STATES THAT THE ISSUE WITH THE LENS WAS THAT IT IS OF INCORRECT POWER. NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE PERFORMED. THE REPLACEMENT LENS USED IS OF SAME MODEL BUT DIFFERENT DIOPTER. THE SUSPECT PRODUCT IS NOT RETUNING FOR EVALUATION. PATIENT WAS ON TARGET AT THE TIME OF DISCHARGE. PATIENT/ USER OUTCOME: VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): 20/50. VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT): 20/60. TARGET REFRACTIVE VALUE PRE-OP (PRE-INITIAL IMPLANT): -0.25. FINAL REFRACTIVE VALUE POST-OP (POST-INITIAL IMPLANT): -0.75 NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 11597091 ↗
• InjurySep 6, 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 A MALE PATIENT¿S RIGHT EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF SYMFONY LENS INTOLERANCE, IRREGULAR AND REGULAR ASTIGMATISM, STARBURSTS AND SPIDER WEB ISSUE IN VISION. A NON-JOHNSON & JOHNSON LENS OF 19.5 DIOPTER WAS USED AS A REPLACEMENT. IT WAS INDICATED THAT NO INCISION ENLARGEMENT WAS DONE; HOWEVER A VITRECTOMY WAS PERFORMED AND LIMBAL RELAXATION INCISION WAS MADE. REPORTEDLY THE PATIENT STATES THAT HIS VISION IS BETTER AND HALOS/GLARE HAVE IMPROVED. THERE WAS NO PATIENT INJURY REPORTED. THE ACCOUNT CONFIRMED THAT THE IOL HAS BEEN DISCARDED.

  Patient problems: Halo; Visual Disturbances; Vitrectomy

  MAUDE report 10498168 ↗
• InjuryAug 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ZXR00 SYMFONY LENS WAS EXPLANTED FROM PATIENT LEFT EYE DUE TO STARBURSTS. ADDITIONALLY INFORMATION STATES ISSUES SIGNIFICANTLY INTERFERED WITH DAILY ACTIVITIES OF LIFE (LIKE READING, DRIVING, ETC.) BY PATIENT EXPERIENCING LOSS OF 2 OR MORE LINES BSCVA. SUTURE WAS PLACED AS PART OF THE STANDARD OF CARE FOR ALL CATARACT SURGERIES. PROCEDURE WAS COMPLETED USING ANOTHER ZKB00 LENS. STARBURSTS WERE IMMEDIATELY GONE DAY ONE POST-OP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected; Visual Disturbances

  MAUDE report 10411830 ↗
• InjuryAug 6, 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. THE PATIENT WAS EXPERIENCING SEVERE GLARE AT DISTANCE AND NEAR AND HALOS AT NIGHT AND WHILE WATCHING TV OR ANYTHING WITH BRIGHT LIGHTS. THE PATIENT ALSO HAD SEVERE DISTANCE AND NEAR VISON BLURRING. A REPLACEMENT LENS OF DIFFERENT MODEL/DIOPTER WAS USED. THERE WAS ONE SUTURE USED. NO PATIENT INJURY WAS REPORTED. PATIENT IS DOING WELL. IT WAS NOTED THAT THE LENS WAS DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 10374922 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXR00 18.5 INTRAOCULAR LENSES (IOL) WAS IMPLANTED IN THE PATIENT¿S LEFT EYE ON (B)(6) 2018 AND REPORTED COMPLAINTS OF GLARE. THROUGH FOLLOW UP, ADDITIONAL INFORMATION WAS RECEIVED STATING ZXR00 18.5 DIOPTER LENS WAS EXPLANTED (B)(6) 2019 DUE TO ADDITIONAL COMPLAINTS OF HYPEROPIC ASTIGMATIC OUTCOME, POSITIVE DYSPHOTOPSIA, VERY POOR NIGHT VISION DUE TO GLARE - UNABLE TO DRIVE AT NIGHT, AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. THERE WAS NO INCISION ENLARGEMENT AND NO PATIENT INJURY. VITRECTOMY (PARS PLANA VITRECTOMY - PPV) AND LIMBAL RELAXING INCISION(S) (LRI) WERE PERFORMED. PATIENT OUTCOME REPORTED AS: PATIENT HAPPY AND FEELS THAT SYMPTOMS HAVE RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; Visual Disturbances; Vitrectomy

  MAUDE report 9827553 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAS BILATERAL ZXR00 INTRAOCULAR LENSES (IOL) IMPLANTED. HOWEVER, THE PATIENT IS EXPERIENCING CIRCLES AND GLARE IN THE FORM OF A HUGE STARBURST AT NIGHT, WHICH HAS LIMITED THE PATIENT FROM DRIVING AT NIGHTTIME. THE SYMPTOMS ARE ALMOST IDENTICAL IN EACH EYES. BOTH LENSES ARE STILL IMPLANTED. PATIENT HAS SEEN HIS EYE DOCTOR MULTIPLE TIMES AND WAS USING EYE DROPS. PER THE PATIENT, NOTHING HAS WORKED TO BETTER HIS NIGHT VISION. PATIENT STATES DAY VISION IS PERFECT BUT IS CONSIDERING A SECOND OPINION TO ADDRESS NIGHT VISION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE EVENT FOR THE RIGHT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE LEFT EYE.

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

  MAUDE report 9796297 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT SURGEON WAS PLANNING TO EXPLANT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS WITH ZCB00 LENS ON (B)(6) 2020 BECAUSE OF PATIENT EXPERIENCING DOUBLE VISION AND WAS NOT ABLE TO READ. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +18.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE ON (B)(6) 2020 AS PER SCHEDULE. THERE WAS NO PATIENT INJURY, NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. REPORTEDLY LENS WITH MODEL ZCB00 AND HIGHER DIOPTER OF +20.0 WAS USED AS REPLACEMENT FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9784330 ↗
• InjuryNov 26, 2019Adverse 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 DUE HALOS DAY AND NIGHT. THE LENS WAS REPLACED WITH A NON J&J LENS. PATIENT WAS REPORTED AS HAPPY POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 9376438 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PATIENT WHO UNDERWENT BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS. SHE IS NOW EXPERIENCING GLARE AT NIGHT, HALOS DURING THE DAY, STARBURSTS, AND AROUND THE STARBURST ARE OTHER LINES. FURTHER INFORMATION PROVIDED STATES THAT THE PATIENT FEELS LIKE SOMEONE HAS POURED OIL IN HER EYE. DOCTOR DID AN YTTRIUM-ALUMINUM-GARNET (YAG) PROCEDURE, BUT IT DID NOT HELP. SHE DOES READ AS WELL AS BEFORE, AND FEELS HER EYESIGHT IS WORSE, AND EYES ARE GLASSY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT HAS GLAUCOMA THAT IS UNDER CONTROL. HER PHYSICIAN TOLD HER IT MIGHT TAKE LONGER FOR HER TO ADAPT, BUT IT HAS BEEN 11 MONTHS. SHE CANNOT SIT IN HER KITCHEN BECAUSE THE LIGHTS OVERHEAD CAUSE HER TO SEE HALOS. SHE SEES HALOS WITH LINES AROUND HEADLIGHTS AND TRAFFIC LIGHTS. SHE HAS HAD DRY EYES BEFORE AND AFTER SURGERY. SHE USES PRESERVATIVE FREE DROPS AND REFRESH OPTIVE. SHE WOULD LIKE TO HAVE THE LENSES EXPLANTED. NO ADDITIONAL INFORMATION WAS RECEIVED. THIS MDR IS FOR THE RIGHT EYE. A SEPARATE MDR IS BEING SUBMITTED FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Glaucoma; Halo

  MAUDE report 9195106 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT HE HAD SYMFONY INTRAOCULAR LENSES (IOLS) IMPLANTED IN BOTH HIS EYES. A MODEL ZXR00, 18.5 DIOPTER LENS WAS INSERTED IN THE PATIENT¿S RIGHT EYE. THE PATIENT REPORTED THAT HE CAN SEE FAR BUT NOT NEAR. HE CANNOT SEE 12 INCHES IN FRONT OF HIM. HE HAD A YAG (YTTRIUM ALUMINUM GARNET) DONE, BUT IT DID NOT HELP MUCH. THRU FOLLOW-UP WITH THE PATIENT, IT WAS LEARNED THAT HE IS EXPERIENCING HALOS, STARBURSTS, AND HAS DIFFICULTY DRIVING AT NIGHT. THIS HAS BEEN HAPPENING SINCE HIS SURGERY. THE PATIENT OFTEN GOES FISHING, BUT THIS TASK IS DIFFICULT AS THE IOLS DO NOT ALLOW YOU TO SEE NEAR ENOUGH TO WORK WITH THE FISH HOOK. PATIENT STATED THAT HE DOES NOT THINK THERE IS ANYTHING WRONG WITH THE IOLS, AND EXPLAINED THAT HE WAS NOT WELL-INFORMED BEFORE THE SURGERY. NO FURTHER INFORMATION WAS PROVIDED. PATIENT HAS BILATERAL IOLS IMPLANTED. THIS REPORT WILL CAPTURE THE PATIENT¿S RIGHT EYE. A SEPARATE REPORT IS BEING FILED FOR THE LEFT EYE.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9164949 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THE FOLLOWING EXPERIENCE. ON (B)(6) 2019, I HAD A TECNIS SYMFONY LENS (DIOPTER +20.0D) IMPLANTED IN MY RIGHT EYE. I COULD READ WELL UP CLOSE WITH THE NEW LENS BUT AT INTERMEDIATE (TV VIEWING) AND FAR DISTANCES (DRIVING) LACKED SHARPNESS AND FOCUS. MY LEFT EYE (WHICH STILL HAS A MILD CATARACT) EXCELLED OVER THE NEW IMPLANT. THE NEW LENS WAS ONLY BETTER AT READING DISTANCES. I TOLD THE DOCTOR THIS AND WE DECIDED TO HAVE A REPLACEMENT SYMFONY LENS (DIOPTER +18.5D) IMPLANTED IN THE RIGHT EYE. NOW MY LEFT EYE BEATS THE RIGHT EYE AT ALL DISTANCES, INCLUDING READING DISTANCE, AS THE RIGHT EYE CAN ONLY READ A RESTAURANT MENU PORTION THAT HAS THE ENLARGED BOLD PRINT. IT'S LIKE I NEED A KNOB ON MY EYE (LIKE A BINOCULARS) TO BRING MY VISION INTO SHARP FOCUS. I AM SO DISAPPOINTED! I HAVE GONE THROUGH THE SURGERY TWICE NOW WITH THE RESULTS WORSE THAN THE FIRST SURGERY. I DON'T KNOW IF I'VE HAD 2 DEFECTIVE LENSES IMPLANTED, THE DOCTOR SCREWED UP, OR YOUR DESCRIPTION OF WHAT THE LENS IS SUPPOSED TO DO IS JUST PLAIN BOGUS: PROVIDES HIGH-QUALITY CONTINUOUS VISION AT NEAR, INTERMEDIATE AND FAR DISTANCES AND POINTS IN BETWEEN. ONE WEBSITE DESCRIBING THE LENS ADDED: WITH NO DROP-O

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9007167 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, A PATIENT IS VERY UNSATISFIED WITH THE SYMFONY INTRAOCULAR LENS (IOL) WHICH WAS IMPLANTED IN HIS OPERATIVE RIGHT (OD) EYE IN (B)(6) OF LAST YEAR. AT THE 1 WEEK POSTOP VISIT, THE PATIENT COMPLAINED OF DISSATISFACTION WITH NEAR AND INTERMEDIATE VISION. HE WAS SEEING NO BETTER THAN J7 IN (B)(6) OF THIS YEAR. THE SURGEON DID PHOTOREFRACTIVE KERATECTOMY (PRK) SURGERY ON HIM TO TRY AND ASSIST WITH THE NEAR VISION PROBLEM. THE VISION HAS ONLY IMPROVED TO J5 AT BEST, AND HE IS 3 MONTHS POST OP PRK SURGERY. THE PATIENT DOES NOT WANT TO HAVE THE LENS EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8808511 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A ZXR00 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT (OS) OPERATIVE EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO A MILD ANISOMETROPIA. THE PATIENT COMPLAINED OF HAVING DIFFICULTY READING, INTOLERANCE, AND DISSATISFACTION WITH OUTCOME. IT IS NOTED OUTCOME SIGNIFICANTLY INTERFERES WITH ACTIVITIES OF DAILY LIFE. THE REPLACEMENT LENS IS A ZLB00 17.5 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8801298 ↗
• InjuryJul 3, 2019Adverse 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 FOR AN UNSPECIFIED REASON. THE LENS WAS DISCARDED. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. FURTHER INFORMATION WAS PROVIDED AND THE PATIENT WAS UNHAPPY WITH HER VISION. THE PATIENT WAS DOING WELL POSTOPERATIVELY WITH NO OTHER COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8761232 ↗
• InjuryJun 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXR00 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE INCORRECT DIOPTER BEING SELECTED. THE EXPLANTED IOL WAS REPLACED WITH THE SAME MODEL IOL OF A LOWER DIOPTER (17.0). THERE WAS NO INTERVENTION REQUIRED AND THE PATIENT WAS DOING WELL POST-EXCHANGE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8737664 ↗
• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POST IMPLANT OF A MODEL ZXR00 18.5 DIOPTER INTRAOCULAR IN THE PATIENT¿S LEFT EYE, THE PATIENT, COMPLAINED OF BLURRY VISION AND DYSPHOTOPSIA. THE IOL WAS EXPLANTED AND REPLACED WITH A MODEL ZCB00 22.0 DIOPTER LENS. THE PATIENT WAS DOING FINE POST-EXCHANGE. NO ADDITIONAL INFORMATION WAS RECEIVED.

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

  MAUDE report 8635012 ↗
• InjuryApr 26, 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 +18.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT NOT HAPPY WITH VISUAL OUTCOME. REPORTEDLY THERE WAS NO PATIENT INJURIES, NO OTHER SURGICAL INTERVENTION, NO CONTRIBUTING MEDICAL HISTORY. PATIENT IS DOING FINE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8558523 ↗