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TECNIS IOL ZXR00 (REF ZXR00U0245)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY ERV 24.5D · Class 3 · Implant

All models of TECNIS IOL (1344)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Johnson & Johnson TECNIS SYMFONY extended depth of focus intraocular lens is implanted during cataract surgery. The 39 adverse event reports mostly describe patients seeing halos, glare, starbursts and blurred vision, with several lenses removed and replaced; others mention the lens tearing during loading through the injector. There are 34 injuries and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
39
Deaths reported
0
Injuries reported
34
Recalls naming it
0

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 05050474579187), received between Nov 28, 2016 and Mar 11, 2024 — classified as 34 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem28
  • Inadequacy of Device Shape and/or Size3
  • Material Split, Cut or Torn2
  • Appropriate Device Problem Term/Code Not Available1
  • Break1
  • Crack1
  • Device Markings/Labelling Problem1
  • Expulsion1

Patient problems

  • No Code Available28
  • Halo10
  • Blurred Vision8
  • Visual Disturbances6
  • Visual Impairment5
  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient2
  • Pain2

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 11, 2024Adverse 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 LEFT EYE DUE TO COMPLAINTS OF BLURRED VISION, AND ¿SEEING THE EDGES OF THE LENS¿. THE IOL WAS REPLACED WITH A LIGHT ADJUSTABLE LENS. THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY, OR SUTURES. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Blurred Vision; Visual Disturbances

    MAUDE report 18876406 ↗
  • InjuryJan 28, 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 RIGHT EYE DUE TO HALO AND GLARE. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED. THERE WAS NO PATIENT INJURY. ANOTHER JOHNSON & JOHNSON LENS (DIFFERENT MODEL AND UNKNOWN DIOPTER) WAS IMPLANTED AS A REPLACEMENT. REPORTEDLY, THE PATIENT IS SEEING WELL POST-EXCHANGE. THE CUSTOMER INDICATED THAT THE LENS HAS BEEN DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Halo; Visual Disturbances

    MAUDE report 13389513 ↗
  • InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE CUSTOMER EXPLANTED AN INTRAOCULAR LENS (IOL) DUE TO VISUAL BLUR WITH INSUFFICIENT NEAR VISION. THE REPLACEMENT LENS WAS OF A DIFFERENT MODEL AND DIOPTER SIZE. PATIENT WAS REPORTEDLY DOING WELL AND HAS BEEN HAPPY WITH THEIR VISION. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: Blurred Vision

    MAUDE report 12791716 ↗
  • InjurySep 21, 2021Mechanical Problem; Mechanical Problem

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO MECHANICAL COMPLICATIONS. ANOTHER JOHNSON & JOHNSON ZXT150 LENS DIOPTER 22.0 (DIFFERENT MODEL AND LOWER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY SUCH AS CAPSULE TEAR AND NO MEDICAL OR SURGICAL INTERVENTION SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES. AT THE TIME OF THIS REPORT, IT WAS STATED THAT THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12510302 ↗
  • MalfunctionMay 17, 2021Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) TORE WHEN THE TECHNICIAN TRIED TO LOAD THE LENS THROUGH THE INJECTOR. THERE WAS PATIENT CONTACT. THROUGH FOLLOW-UP, IT WAS LEARNED THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING FINE WITH NO ISSUES. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) THE BACK-UP LENS, WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11837649 ↗
  • InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT REPORTED THAT AFTER THE IMPLANTATION OF A TECNIS SYMFONY INTRAOCULAR LENS (IOL) IN HER RIGHT (OD) EYE, HER VISION IMPROVED, BUT OVER TIME THIS VISION DECREASED. THE PATIENT EXPERIENCED STARBURSTS WHILE LOOKING AT LIGHTS, IN WHICH THE DOCTOR PERFORMED A PRK (PHOTOREFRACTIVE KERATECTOMY). THE PATIENT IS STILL EXPERIENCING THE STARBURSTS AND CANNOT DRIVE AS A RESULT. ALSO, WHEN TRYING TO READ, IT SEEMS THE LETTERS ARE ALL SMOOSHED TOGETHER, WHICH REQUIRES READING GLASSES. DRY EYE PRESCRIPTION DROPS AND PLUGS, RESTASIS AND XIIDRA WERE PRESCRIBED. LENS REMAINS IMPLANTED UNTIL SHE RECEIVED ADDITIONAL CONSULTATION FROM THE HEALTHCARE PROVIDER. NO ADDITIONAL INFORMATION PROVIDED. THE PATIENT HAS BILATERAL IMPLANTS. THIS REPORT REPRESENTS THE RIGHT (OD) EYE. A SEPARATE REPORT IS SUBMITTED FOR THE LEFT (OS) EYE.

    Patient problems: Dry Eye(s); Visual Disturbances; Visual Impairment

    MAUDE report 10909215 ↗
  • InjuryMar 18, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    IT WAS REPORTED THAT A ZXR00 24.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE AND WAS LATER EXPLANTED. REASON FOR EXPLANT WAS NOT PROVIDED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT LOWER DIOPTER. AT EXCHANGE, THERE WAS NO INCISION ENLARGEMENT AND NO INJURY REPORTED. THE CURRENT PATIENT STATUS WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 9846419 ↗
  • InjuryMar 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT PATIENT UNDERWENT CATARACT SURGERY IN (B)(6) 2019 FOR HER BOTH EYES. AFTER THE SURGERY SHE IS EXPERIENCING HALOS AND STARBURST. HER VISION IS GOOD BESIDES AND USES GLASSES FOR CLOSE UP VISION. SHE REPORTED THIS TO HER SURGEON IN (B)(6)2019 AND WAS TOLD TO SEE HIM NEXT YEAR. SHE SAW THE DOCTOR IN (B)(6) 2020 AND A NIGHT TEST WAS DONE TO EVALUATE HER VISION. HOWEVER, SHE SAID THE LIGHTS THEY USED WERE NOT INDICATIVE OF WHAT SHE ACTUALLY SEES WHEN SHE¿S DRIVING. SHE STATED THAT THE HALOS AND STARBURSTS OCCUR AROUND ANY LIGHT SOURCE. IT IS SEVERE ENOUGH TO WHERE SHE HAS STOPPED DRIVING AT NIGHT, OUT OF CONCERN SHE COULD EASILY GET INTO AN ACCIDENT. IN ADDITION, SHE WAS TOLD THERE WAS NO SCAR TISSUE AND THAT LASIK WOULD NOT HELP. SHE WAS PRESCRIBED GLASSES TO HELP WITH THE ISSUE, BUT IT DOESN¿T WORK. HER DOCTOR DIDN¿T ADVISE HER ABOUT HOW TO IMPROVE THE ISSUE, BUT STATED IT IS BETTER THAN A CATARACT, AND THAT HE¿D SEE HER NEXT YEAR. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT DOCTOR PRESCRIBED HER WITH PILOCARPINE EYE DROPS WHICH LEAD TO MIGRAINE AND PAIN. IT ALTHOUGH TEMPORARILY HELPED WITH HALOS HOWEVER MIGRAINE WAS VERY BAD. SHE ADDED THAT SHE CANN

    Patient problems: Halo; No Code Available; Pain; Visual Disturbances

    MAUDE report 9804079 ↗
  • InjuryMar 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT PATIENT UNDERWENT CATARACT SURGERY IN (B)(6) 2019 FOR HER BOTH EYES. AFTER THE SURGERY SHE IS EXPERIENCING HALOS AND STARBURST. HER VISION IS GOOD BESIDES AND USES GLASSES FOR CLOSE UP VISION. SHE REPORTED THIS TO HER SURGEON IN (B)(6) 2019 AND WAS TOLD TO SEE HIM NEXT YEAR. SHE SAW THE DOCTOR IN (B)(6) 2020 AND A NIGHT TEST WAS DONE TO EVALUATE HER VISION. HOWEVER, SHE SAID THE LIGHTS THEY USED WERE NOT INDICATIVE OF WHAT SHE ACTUALLY SEES WHEN SHE¿S DRIVING. SHE STATED THAT THE HALOS AND STARBURSTS OCCUR AROUND ANY LIGHT SOURCE. IT IS SEVERE ENOUGH TO WHERE SHE HAS STOPPED DRIVING AT NIGHT, OUT OF CONCERN SHE COULD EASILY GET INTO AN ACCIDENT. IN ADDITION, SHE WAS TOLD THERE WAS NO SCAR TISSUE AND THAT LASIK WOULD NOT HELP. SHE WAS PRESCRIBED GLASSES TO HELP WITH THE ISSUE, BUT IT DOESN¿T WORK. HER DOCTOR DIDN¿T ADVISE HER ABOUT HOW TO IMPROVE THE ISSUE, BUT STATED IT IS BETTER THAN A CATARACT, AND THAT HE¿D SEE HER NEXT YEAR. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT DOCTOR PRESCRIBED HER WITH PILOCARPINE EYE DROPS WHICH LEAD TO MIGRAINE AND PAIN. IT ALTHOUGH TEMPORARILY HELPED WITH HALOS HOWEVER MIGRAINE WAS VERY BAD. SHE ADDED THAT SHE CAN

    Patient problems: Halo; No Code Available; Pain; Visual Disturbances

    MAUDE report 9804073 ↗
  • InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A SYMFONY INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A PATIENTS COMPLAINT. ADDITIONAL INFORMATION RECEIVED REPORTED THE IOL WAS EXPLANTED FROM THE LEFT EYE BY A SURGEON DIFFERENT FROM THE IMPLANTING SURGEON. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 9695257 ↗
  • InjuryDec 20, 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 REMOVED FROM THE PATIENT¿S RIGHT EYE, DUE TO UNACCEPTABLE/INTOLERABLE HALOS, GLARE AND DYSPHOTOPSIA. THERE WAS INCISION ENLARGEMENT. THE SUSPECT IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: Halo; No Code Available

    MAUDE report 9501308 ↗
  • InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A ZXR00 24.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO BLURRY VISION. THE REPLACEMENT LENS IS A NON-JOHNSON AND JOHNSON LENS AND THE PATIENT WAS REPORTED TO BE DOING WELL POST EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Blurred Vision; No Code Available

    MAUDE report 9379768 ↗
  • InjuryNov 20, 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 TO AN IOL POWER MISS. PATIENT EXPERIENCED BLURRED VISION. THE LENS WAS REPLACED WITH THE SAME MODEL, A SMALLER, 22.0 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Blurred Vision; No Code Available

    MAUDE report 9346440 ↗
  • InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT HAD A MYOPIC SURPRISE. THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AND WAS REPLACED WITH THE SAME MODEL WITH A LOWER DIOPTER 23.0 LENS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Patient problems: No Code Available

    MAUDE report 9037890 ↗
  • InjuryAug 21, 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 EXPLANTED. THERE WAS NO INTERVENTION PERFORMED. ADDITIONAL INFORMATION OBTAINED REVEALED THE LENS WAS EXPLANTED FROM THE PATIENTS RIGHT EYE DUE TO BLURRY VISION. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Patient problems: Blurred Vision; No Code Available

    MAUDE report 8914529 ↗
  • InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT COULD NOT TOLERATE THE GLARE POST-IMPLANT OF A ZXR00 INTRAOCULAR LENS (IOL). THE IOL WAS EXPLANTED AND REPLACE WITH AN IOL OF A DIFFERENT MODEL. THE EXPLANTED IOL WAS DISCARDED. REQUESTS WERE MADE FOR ADDITIONAL INFORMATION BUT NO RESPONSE WAS RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 8899346 ↗
  • InjuryJul 31, 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 EXPLANTED FROM THE PATIENT'S LEFT EYE AS THE PATIENT NEEDED A DIFFERENT POWER OF TORIC. THE REPLACEMENT LENS WAS THE SAME MODEL BUT DIFFERENT DIOPTER (22.5). THERE WAS NO ADDITIONAL INTERVENTION PERFORMED AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 8844548 ↗
  • InjuryJul 10, 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 A FEMALE PATIENT. ABOUT 2 MONTHS LATER, THE DOCTOR STATED THAT THE IOL HAD TO BE REMOVED DUE TO LENS COMPLICATION NOTED AS THE PATIENT DEVELOPED BLURRY VISION. PRE-OP VISUAL ACUITY (VA) 20/100, POST-OP VA 20/200. SEVERAL FOLLOW-UPS WERE DONE TO ASK FOR CLARIFICATION AND OBTAIN OTHER INFORMATION BUT THERE WAS NO RESPONSE RECEIVED.

    Patient problems: Blurred Vision; No Code Available

    MAUDE report 8778841 ↗
  • InjuryJun 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS INITIALLY REPORTED THAT THE INTRAOCULAR LENS (IOL) LENS WAS POSSIBLY GOING TO BE EXCHANGED WITH NO OTHER INFORMATION PROVIDED. AT A LATER DATE FURTHER INFORMATION WAS PROVIDED. IT WAS LEARNED THAT THE PATIENT ENDED UP MORE NEAR SIGHTED, THEREFORE, THE LENS WAS EXPLANTED. THE IOL HAS BEEN DISCARDED. REPORTEDLY, THE INCISION WAS ENLARGED, BUT THERE WERE NO SUTURES AND NO VITRECTOMY REQUIRED. THE VISUAL ACUITY PRE-OPERATIVE 20/200 UNCORRECTED, VISUAL ACUITY POST-OPERATIVE 20/30 -2 WITHOUT CORRECTION. ANOTHER LENS (SAME MODEL BUT A LOWER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING WELL POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Patient problems: No Code Available

    MAUDE report 8698131 ↗
  • InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A ZXR00, 24.5 DIOPTER INTRAOCULAR LENS (IOL), WAS EXPLANTED FROM THE RIGHT EYE DUE TO MYOPIC MISS. THE VISUAL SYMPTOMS INTERFERED WITH THE PATIENT'S REGULAR ACTIVITIES. IT WAS NOTED THAT THE SUSPECT LENS WAS REPLACED WITH A SAME MODEL IOL BUT DIFFERENT DIOPTER (23.0). THE PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) 20/40 +2 J7 AND POST-OP BCVA 20/25. THE PATIENT WAS NOTED TO BE FINE POST-OP. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 8534550 ↗
  • InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED BECAUSE THE PATIENT EXPERIENCED POOR VISUAL ACUITY, GLARE, AND NOCTURNAL STARBURSTS. THE LENS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. VISUAL ACUITY PRE-OP 20/25 WITH GLARE TESTING TO 20/40. VISUAL ACUITY POST-OP 20/20 WITH CORRECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Code Available; Visual Disturbances; Visual Impairment

    MAUDE report 8498288 ↗
  • InjuryOct 17, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

    IT WAS REPORTED THAT THE TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +24.5 DIOPTER) TORE ON UPON INSERTION INTO THE EYE. THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. REPORTEDLY A VITRECTOMY, INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. NO FURTHER INFORMATION PROVIDED.

    Patient problems: No Code Available; Vitrectomy

    MAUDE report 7976176 ↗
  • InjuryAug 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A ZXROO INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S EYE DUE TO REFRACTIVE ERROR/POWER MISS. A LENS EXCHANGE WAS PERFORMED (B)(6) 2018, WITHOUT COMPLICATION. THERE WAS NO PATIENT INJURY, NO INCISION ENLARGEMENT, AND NO SUTURES REQUIRED. NO ADDITIONAL INFORMATION PROVIDED.

    Patient problems: No Code Available

    MAUDE report 7765735 ↗
  • InjuryApr 14, 2018Expulsion; Expulsion

    IT WAS REPORTED THAT A ZXR00 24.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO UNEXPECTED POST-OPERATIVE REFRACTION THAT SIGNIFICANTLY INTERFERES WITH THE PATIENT'S ACTIVITIES OF DAILY LIFE. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY, BUT ONE (1) SUTURE WAS USED TO THE SIDE PORT. THE REPLACEMENT LENS WAS THE SAME DIOPTER, BUT DIFFERENT MODEL ZKB00. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 7431540 ↗
  • InjuryJan 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A PATIENT CALLED AND REPORTED THAT SHE HAD A ZXR00 24.5 DIOPTER INTRAOCULAR LENS (IOL) IMPLANTED IN HER OPERATIVE EYE ON (B)(6) 2017. POST-OPERATIVELY, SHE EXPERIENCED A MACULAR PUCKER AND WAS NOT HAPPY. SHE WAS UNABLE TO DRIVE AT NIGHT AND SAW HALOS AROUND LIGHTS. FURTHERMORE, SHE DEVELOPED AN EPIRETINAL MEMBRANE AFTER THE INITIAL IMPLANT AND HAS BEEN ON PREDNISONE SINCE. REPORTEDLY, SHE HAD THE LENS REMOVED AND REPLACED WITH A MONOFOCAL LENS, WHICH WAS PERFORMED BY ANOTHER DOCTOR DURING (B)(6) OF 2017. POST-OPERATIVELY, THE PATIENT HAS NO COMPLAINTS ABOUT HER VISION WITH THE NEW LENS. THE PATIENT HAS BEEN ON ANTI-INFLAMMATORY MEDICATION SINCE MARCH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Halo; No Code Available; Visual Impairment

    MAUDE report 7214439 ↗

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