TECNIS IOL ZXR00 (REF ZXR00U0175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 05050474579040), received between Nov 29, 2016 and Oct 2, 2023 — classified as 42 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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 44 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 (B)(6) 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. ADD

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

  MAUDE report 17854099 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S VISION WAS HAZY AT ALL RANGES. AFFECTED EYE IS THE LEFT EYE. THERE WAS NO PATIENT INJURY. NO VITRECTOMY AND NO INCISION ENLARGEMENT. THE DIOPTER FOR THE REPLACEMENT LENS IS 16.5 (NON JNJ LENS). THE PATIENT OUTCOME IS ¿GOOD¿.

  Patient problems: Blurred Vision

  MAUDE report 16823122 ↗
• InjuryApr 5, 2022Material Discolored; Material Discolored

  RECEIVED REPORT FROM A PATIENT INDICATING HER LEFT EYE IS FOR CLOSE-UP READING. THE PATIENT EXPLAINED THAT WHEN SHE READS THE VISION IN HER LEFT EYE IS A LITTLE BLURRY. SHE IS VERY DISAPPOINTED WITH THAT OUTCOME. THE PATIENT PROVIDED THAT WHEN SHE FIRST WALKED OUT OF THE OFFICE AFTER HER IMPLANT SHE LOOKED AROUND AND HER VISION WAS CLEAR. SHE WAS HAPPY. HOWEVER, SHE WAS NOT TRYING TO READ ANYTHING UP CLOSE. SHE DID NOT TRY TO READ UNTIL A COUPLE OF WEEKS LATER. THAT IS WHEN SHE NOTICED HER READING VISION WAS BLURRY. THE BLURRINESS IS WITHIN ARMS-LENGTH. THE DOCTOR TOLD HER THAT THE IOL SEEMED A LITTLE HAZY AND PERFORMED YTTRIUM ALUMINUM GARNET (YAG) LASIK SURGERY ON (B)(6) 2021. THE PATIENT SAID IT DID NOT HELP. PATIENT STATED SHE¿S HEALTHY, DOES NOT HAVE HIGH BLOOD PRESSURE AND IS NOT ON ANY PRESCRIPTION MEDICATION. SHE ONLY TAKES VITAMINS. REPORTEDLY, THE DOCTOR EXPLAINED TO HER THAT SHE NEEDED TIME TO ALLOW FOR NEUROADAPTATION. FIRST THE DOCTOR SAID TO GIVE IT A COUPLE OF WEEKS BUT THEN HE EXTENDED IT TO A COUPLE OF MONTHS. HE THEN PRESCRIBED GLASSES. SHE GOT GLASSES ON (B)(6) 2021. THE GLASSES WERE NOT WORKING FOR HER EITHER. THE DOCTOR MODIFIED HER PRESCRIPTION SLIGHTLY ON (B)

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

  MAUDE report 14018215 ↗
• InjuryOct 28, 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 A PATIENT¿S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO MECHANICAL FAILURE OF THE LENS. THE PATIENT HAD DECREASED NEAR VISION AFTER THE IOL WAS IMPLANTED AND STATED HE WAS UNABLE TO READ. THE PATIENT ALSO COMPLAINED OF SIGNIFICANT GLARE/STARBURSTS AROUND LIGHTS WITH NEW LENSES THAT DID NOT IMPROVE OVER TIME. PATIENT'S MOST RECENT COMPLAINT WAS ON (B)(6) 2021 WHEN HE RETURNED TO THE DOCTOR¿S OFFICE FOR DISCUSSION OF IOL EXCHANGE. A REPLACEMENT LENS OF DIFFERENT MODEL, DFR00V AND 16.5 DIOPTER WAS USED. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY REQUIRED. THE PATIENT WAS REPORTED TO BE DOING FINE. NO FURTHER INFORMATION WAS PROVIDED. INITIAL PRE-OP VISUAL ACUITY: UNCORRECTED VISUAL ACUITY RIGHT EYE (OD): 20/30 AT DISTANCE, 20/30 AT NEAR. POST-OP VISUAL ACUITY AFTER ORIGINAL L LENS IMPLANTED: UNCORRECTED 20/80 DISTANCE, NEAR 20/400 CHECKED AFTER IMPLANT ON (B)(6) 2019, MOST RECENT VISUAL ACUITY PRIOR TO EXPLANT FOR OD UNCORRECTED: 20/30 AT DISTANCE, 20/100 AT NEAR. POST-OP VISUAL ACUITY AFTER DFR00V LENS WAS IMPLANTED: 8 DAYS AFTER SURGERY, 20/50 DISTANCE, 20/100 NEAR (PATIENT HAS NOT HAD FURTHER POST-OP

  Patient problems: Blurred Vision; Flashers; Visual Disturbances

  MAUDE report 12708913 ↗
• InjurySep 9, 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 RIGHT EYE DUE TO MULTIFOCAL LENS INTOLERANCE. THE PATIENT HAD SEVERE GLARE DUE THE PATIENT WAS UNABLE TO DRIVE AT NIGHT. THE PATIENT ALSO HAD BLURRY VISION FOR DISTANCE, NEAR, AND COMPUTER RANGE AND HAD LIGHT SENSITIVITY UNDER ALL LIGHTING CONDITIONS. THE PATIENT NOTICED THE SYMPTOMS RIGHT AFTER THE SURGERY. THE IOL HAS BEEN DISCARDED. ANOTHER COMPETITOR LENS WAS PLACED AS THE REPLACEMENT AND THE PATIENT OUTCOME WAS EXCELLENT. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12450984 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A PATIENT WITH POOR VISUAL ACUITY OUTCOME WITH AN INTRAOCULAR LENS (IOL) WILL HAVE AN IOL EXCHANGE. THROUGH FOLLOW-UP, IT WAS LEARNED THE PATIENT HAD A REFRACTIVE CLEAR LENS EXCHANGE AS THE PATIENT DID NOT HAVE CATARACTS PRE-OPERATIVE. VISUAL ACUITY (VA) PRE-OP: UNCORRECTED VISUAL ACUITY (UCVA): 20/300 J1. J10 20/20 IS THE BEST THE PATIENT HAS EVER MEASURED POST-OPERATIVE. THE DISTANCE VISUAL ACUITY (VA) IS GREAT, BUT PATIENT HAS POOR INTERMEDIATE/NEAR VA OR BLURRY NEAR VISION POST-OP. A YTTRIUM ALUMINUM GARNET (YAG) LASER WAS PERFORMED ON (B)(6) 2020 AND THE DRY EYE WAS TREATED. A SECONDARY SURGERY/MEDICAL INTERVENTION IS NOT REQUIRED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. NOR IS AN EXPLANT PLANNED. THE LENS REMAINS IMPLANTED AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Dry Eye(s)

  MAUDE report 11661773 ↗
• 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 SINISTER (LEFT 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 SEVERAL 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 OCU

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

  MAUDE report 11325689 ↗
• MalfunctionFeb 1, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE PATIENT'S EYE, BUT WAS REMOVED AND REPLACED DUE TO SCRATCH ON THE IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11264130 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WAS IMPLANTED WITH A SYMFONY INTRAOCULAR LENS (IOL), BUT SHE DEVELOPED BLURRY NEAR VISION. DISTANCE VISUAL ACUITY WAS GREAT, BUT THE PATIENT HAS POOR INTERMEDIATE/NEAR VISUAL ACUITY. J10 IS THE BEST THAT SHE HAD EVER MEASURED. THE PATIENT DID NOT HAVE CATARACTS PRE-OP, THE INITIAL PROCEDURE WAS A CLEAR LENS EXCHANGE (CLEAR LENS EXTRACTION). A YTTRIUM-ALUMINUM GARNET (YAG) CAPSULOTOMY WAS CONDUCTED AND DRY EYE TREATED. FOLLOW-UP CONFIRMED THE YAG CAPSULOTOMY WAS DONE FOLLOWING SURGERY DUE TO A POSTERIOR CAPSULE OPACIFICATION THAT WAS TREATED WITH A LASER. THE CUSTOMER THOUGHT THIS WOULD SOLVE THE DIFFICULTY WITH THE PATIENT¿S NEAR VISION AND THUS FELT THIS WAS THE BEST TREATMENT FOR HER AT THE TIME. UNFORTUNATELY, IT DIDN¿T HELP AND THE IOL COULD NO LONGER BE EXPLANTED. THE PATIENT HAS DRY EYE WHICH THEY TRY TO TREAT TO ALSO SEE IF THIS WAS WHY THE PATIENT DIDN¿T ACHIEVE GOOD NEAR/INTERMEDIATE VISION FROM THE SYMFONY IOL. UNFORTUNATELY, THIS DID NOT RESOLVE HER SYMPTOMS EITHER. NEVERTHELESS, THE PATIENT HAS GREAT DISTANCE VISION POST-OP. THE GOAL WAS TO REDUCE THE PATIENT¿S DEPENDENCE ON READERS BUT THIS DID NOT HAPPEN. PRE-OPERATIVE UNCORRECTED

  Patient problems: Blurred Vision; Therapeutic Effects, Unexpected; Visual Impairment

  MAUDE report 11092900 ↗
• 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 LEFT 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 LEFT EYE AND A SEPARATE REPORT IS BEING FILED FOR CAPTURING ISSUE IN THE RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 11024195 ↗
• InjuryOct 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A ZXR00 MODEL INTRAOCULAR LENS(IOL) WAS INSERTED INTO THE PATIENT''S RIGHT EYE BY THE SURGEON AND IT IMMEDIATELY FELL TO THE BACK OF THE EYE. SURGEON OPTED TO INSERT SILICONE LENS IN THE SULCUS. 10.L0 NYLON X 1 RADIAL SUTURES WERE PERFORMED. THERE WAS NO DELAY IN PROCEDURE. PATIENT HAS AN APPOINTMENT FOR RETINAL CONSULT, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10708906 ↗
• InjuryAug 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CUSTOMER HAS AN UPCOMING INTRAOCULAR LENS (IOL) EXCHANGE FOR A PATIENT WHO HAD A SYMFONY IOL IMPLANTED IN HIS LEFT EYE. IT WAS LEARNED THAT AS THE DEVICE HAS BEEN IMPLANTED FOR MORE THAN A YEAR NOW, THE PATIENT¿S VISUAL ISSUES SIGNIFICANTLY INTERFERES WITH HIS REGULAR ACTIVITIES, DESCRIBED AS HAVING DIFFICULTY SEEING HIS BIKE¿S COMPUTER AS WELL AS HAVING GLARES & HALOS. ALSO, THE PATIENT IS UNHAPPY WITH HIS NEAR VISUAL OUTCOMES HENCE, THE DOCTOR PLANS TO HAVE IT BE REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Impairment

  MAUDE report 10383096 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD CATARACT SURGERY ON (B)(6) 2019 IN PATIENT¿S RIGHT EYE WHEN LENS WITH MODEL ZXR00 +17.5 DIOPTER WAS IMPLANTED. LENS WAS LATER EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING GLARE, HALOS AND TROUBLE READING. THERE WAS NO CAPSULAR TEAR. NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. REPORTEDLY LENS WITH ANOTHER MODEL ZMB00 WITH HIGHER DIOPTER OF 18.5 WAS USED AS REPLACEMENT LENS. LENS EXCHANGE WENT WELL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9846353 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH TECNIS SYMFONY LENSES BILATERALLY ON (B)(6) 2019 AND (B)(6) 2019. THE PATIENT WAS EXPERIENCING HAZE AND GLARE WITH LIGHTS AT NIGHT AND WAS UNABLE TO DRIVE. SURGEON EVALUATED THE PATIENT AND DECIDED TO EXCHANGE THE LENS FOR A REGULAR LENS. SURGEON EXPLANTED LENS FROM PATIENT¿S RIGHT EYE ON (B)(6) 2020 AND LEFT EYE WAS SCHEDULED TO BE EXPLANTED ON (B)(6) 2020. THE VISUAL ACUITY PRE-OP WAS REPORTED AS 20/30 AND POST OP VISUAL ACUITY WAS REPORTED AS 20/20. REPORTEDLY TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +17.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND NO VITRECTOMY REQUIRED. THIS REPORT WILL CAPTURE INFORMATION ABOUT PATIENT¿S RIGHT EYE AND A SEPARATE REPORT IS BEING SUBMITTED FOR PATIENT¿S LEFT EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9835874 ↗
• InjuryDec 28, 2019Adverse 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 LEFT EYE. PATIENT STATED THAT THE VISION WAS CLEARER RIGHT AFTER SURGERY BUT DUE TO HALOS, STARBURSTS, POSITIVE DYSPHOTOPSIA, AND INABILITY TO DRIVE AT NIGHT THE LENS WAS EXPLANTED/EXCHANGED. A PARS PLANA VITRECTOMY AND LIMBAL RELAXATION INCISION WERE PERFORMED. THE REPLACEMENT LENS WAS NON-JOHNSON & JOHNSON IOL. THERE WAS NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances; Vitrectomy

  MAUDE report 9528280 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD BILATERAL INTRAOCULAR LENS IMPLANTS IN HER EYES ABOUT 5 WEEKS AGO. FOLLOW-UP CONFIRMED THAT THE LENSES ARE A ZXT150, LEFT EYE (OS) AND A ZXR00, RIGHT EYE (OD). PATIENT STATED THAT HER VISION DIDN'T CHANGE EVEN AFTER >1 MONTH IMPLANT. SHE NEEDS READERS TO BE ABLE TO GO ABOUT HER DAILY ACTIVITIES. FURTHER INFORMATION WAS RECEIVED RECENTLY WHERE IT WAS REPORTED THAT AFTER ABOUT 4 MONTHS POST-OP, THE INTRAOCULAR LENS (IOL) IN THE PATIENT¿S RIGHT EYE WAS EXPLANTED. THIS WAS DUE TO PATIENT STILL BEING UNHAPPY WITH THE QUALITY OF THE LENS. SECONDARY TO PATIENT NOT BEING ABLE TO SEE DISTANCE, SHE ALSO SAW FIREWORKS WHEN LOOKING AT STREET SIGNS, AND HAD DIPLOPIA AS WELL. POST OP, GLARE IS BETTER AND HALOS DECREASED. THE PATIENT IS SCHEDULED TO HAVE LEFT IOL EXCHANGE IN THE FUTURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9406374 ↗
• InjuryNov 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 17.5 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 BLURRY VISION, STARBURST SHAPES IN LIGHTING AT NIGHT, AND HYPEROPIC SURPRISE OUTCOME. PATIENT'S VISUAL ACUITY PRE-OP WAS 20/100 AND POST-OP IS 20/30. REPORTEDLY, THERE WAS NO SURGICAL INTERVENTION REQUIRED AND THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 9288603 ↗
• InjuryOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WILL BE EXCHANGED AT A LATER DATE DUE TO A POST OP REFRACTION OF +1.50 SE (SPHERE EQUIVALENT). THE DATE OF EXCHANGE WILL BE (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9173898 ↗
• InjuryJun 10, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A ZXR00 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER REMOVED ON (B)(6) 2019 DUE TO UNSPECIFIED LENS MALFUNCTION. THERE WAS NO INCISION ENLARGEMENT OR SUTURE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS OF THE SAME MODEL AND DIOPTER. REPORTEDLY, PATIENT IS DOING WELL POST OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8685605 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IOL MODEL ZXR00 17.5 DIOPTER WAS EXPLANTED DUE TO THE PATIENT WAS DISSATISFIED WITH THEIR NEAR AND FAR VISION. A VITRECTOMY WAS PERFORMED. THE LENS WAS REPLACED WITH A NON JOHNSON AND JOHNSON IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8568636 ↗
• InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED A BILATERAL INTRAOCULAR LENS (IOL) IMPLANT. SOON AFTER THE IMPLANTATION, THE PATIENT STARTED COMPLAINING THAT HIS VISION WAS GETTING WORSE. REPORTEDLY, THE PATIENT HAS BEEN EXPERIENCING BLURRY VISION AT ALL DISTANCES THAT IS SIGNIFICANTLY AFFECTING HIS ABILITY TO PERFORM ACTIVITIES SUCH AS DRIVING ESPECIALLY AT NIGHT. THE LENS REMAINS IMPLANTED AND THE SURGEON MENTIONED PERFORMING A YAG (YTTRIUM ALUMINUM GARNET) TO HELP IMPROVE THE VISION BUT THERE IS NOTHING PLANNED/SCHEDULED AS THIS TIME. NO ADDITIONAL INFORMATION WAS RECEIVED BY JOHNSON AND JOHNSON SURGICAL VISION. THIS MDR CAPTURES THE EVENT FOR THE RIGHT EYE (OD). A SEPARATE MDR WILL BE FILED FOR THE LEFT EYE (OS).

  Patient problems: Blurred Vision

  MAUDE report 8490679 ↗
• InjuryApr 5, 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 FROM THE PATIENT'S RIGHT EYE, DUE TO COMPLAINT OF SEVERE GLARE. THE LENS WAS REPLACED WITH A NON JOHNSON & JOHNSON LENS. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS REQUIRED AND NO OTHER SURGICAL OR MEDICAL INTERVENTION WAS PERFORMED OR PLANNED. REPORTEDLY, POST-LENS EXCHANGE THE PATIENT STILL COMPLAINTS OF GLARE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8486052 ↗
• InjuryDec 21, 2018Adverse 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 EXPLANTED ON (B)(6) 2018. THE IOL WAS EXPLANTED DUE TO UNEXPECTED POST-OP REFRACTION AND THE PATIENT'S COMPLAINT OF BLURRY VISION. THE IOL WAS INITIALLY IMPLANTED INTO THE PATIENTS RIGHT EYE ON (B)(6) 2018 WITH THE PATIENT COMPLAINT OF BLURRY VISION ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8192160 ↗
• InjuryDec 6, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ZXR00 SYMFONY INTRAOCULAR LENS (IOL) WAS PLANNED TO BE EXCHANGE ON (B)(6) 2018, FROM THE RIGHT EYE OF A MALE PATIENT. REPORTEDLY, THE PATIENT COMPLAINED OF DIFFICULTY READING, GLARE AND SHADOWS. ADDITIONALLY, IOL DECENTRATION AND MECHANICAL COMPLICATIONS OF THE IOL WERE REPORTED. PRE-OPERATIVE DVA (DISTANCE VISUAL ACUITY) 20/30. POST-OPERATIVE DVA 20/30. POST-OPERATIVE NVA (NEAR VISUAL ACUITY) 20/70. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8137036 ↗
• InjuryNov 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +17.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE OF THE PATIENT EXPERIENCING UNACCEPTABLE GLARE AND DYSPHOTOPSIA. THE REPLACEMENT LENS WAS A MONOFOCAL, MODEL PCB00. REPORTEDLY INCISION ENLARGEMENT WAS PERFORMED. THERE WAS NO SUTURES AND NO VITRECTOMY PERFORMED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8027120 ↗