TECNIS IOL ZXR00 (REF ZXR00U0235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 05050474579163), received between Dec 5, 2016 and Nov 4, 2022 — classified as 47 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 6, 2023Class IIOpen, Classified

   Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.

   Z-2288-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2022Adverse 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 FOR AN UNSPECIFIED REASON. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO THE PATIENT COMPLAINING A THICK FILM OVER VISION AND MADE IT HARD TO SEE. VISION WAS CLOUDY, MILKY, AND BLURRY. THE PATIENT COULD NOT DRIVE OR READ. THERE WAS NO REPORT OF ANY UNPLANNED VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES WERE REQUIRED. THERE WAS NO PATIENT INJURY. ANOTHER JOHNSON & JOHNSON LENS, SAME MODEL ZXR00 AND HIGHER 24.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 15726127 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BLURRY VISION WITH DAILY ACTIVITIES SIGNIFICANTLY AFFECTED. THE PATIENT'S VISION PRE-OPERATIVE WAS 20/60 AND POST-OPERATIVE 20/200. AN EXPLANT WAS PERFORMED APPROXIMATELY TWO MONTHS AFTER THE IMPLANTATION. THE INTRA-OCULAR LENS (IOL) WILL NOT BE RETURNED FOR INVESTIGATION AS IT WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 14558587 ↗
• InjuryNov 2, 2021Material Opacification; Material Opacification

  DOCTOR REPORTED THAT HIS PATIENT HAD VISUALLY SIGNIFICANT CATARACTS AND UNDERWENT CATARACT SURGERY ON (B)(6) 2021 IN HIS RIGHT EYE DURING WHICH A TECNIS SYMPHONY INTRAOCULAR LENS (IOL) MODEL ZXR00 WAS IMPLANTED. POST OPERATIVELY THEIR VISUAL ACUITY (VA) WAS PROVIDED AS 20/30 AND WITH -0.25+0.25 X 45 VA WAS 20/25, BUT PATIENT HAS ¿SEVERE STARBURST AND GLARE WITH OD (RIGHT EYE). THE SLIT LAMP EXAM SHOWED WHAT THE DOCTOR DESCRIBED AS POWDERY DEPOSITS ON THE IOL AT THE EDGES OF THE MULTIFOCAL ESCHELETTES. REPORTEDLY, THERE WAS NO INTRACAMERAL MEDICATIONS INJECTED IN THE ANTERIOR CHAMBER. THROUGH FOLLOW-UP THE DOCTOR ALSO REPORTED UNEXPECTED POST-OPERATIVE OUTCOME. POST-OPERATIVE MEDICATIONS INCLUDE PREDNISOLONE ACETATE 1% QID, OFLOXACIN QID, KETOROLAC BID. THE DOCTOR CLARIFIED THAT THE PHACOEMULSIFICATION SURGERY WAS UNEVENTFUL AND THE SYMPTOMS WERE PRESENT ONE DAY POST IMPLANTATION. IN ADDITION, SINCE THE LEFT EYE HAS A SYMFONY LENS THAT WAS IMPLANTED ON (B)(6) 2021 THE PATIENT HAS A GOOD POINT OF REFERENCE. THE DOCTOR DISCUSSED PERFORMING AN IOL EXCHANGE; HOWEVER, THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Visual Disturbances; Visual Impairment

  MAUDE report 12741227 ↗
• InjuryMay 28, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A ZXR00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE (OS) IN A SECONDARY SURGERY DUE TO MECHANICAL COMPLICATIONS WITH THE LENS. AT EXPLANT THERE WAS NO SURGICAL INTERVENTION, VITRECTOMY, SUTURES OR INCISION ENLARGED. THERE WAS NO INJURY INDICATED. ANOTHER JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT, SAME MODEL, BUT LOWER DIOPTER 21.5. THE PATIENT IS DOING FINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11899286 ↗
• InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF HALOS AND GLARE, THEREFORE, AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT WAS UNABLE TO DRIVE AT NIGHT DUE TO THE SEVERE HALOS AND GLARE. VISUAL ACUITY (VA) PRE-OPERATIVE: 20/50, VA POST-OP: 20/50. DURING EXPLANT, THE INCISION WAS ENLARGED AND A SINGLE SUTURE WAS REQUIRED. A VITRECTOMY WAS NOT REQUIRED. ANOTHER JOHNSON & JOHNSON LENS, MODEL ZCB00, 24.5 DIOPTER WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 10597636 ↗
• InjurySep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ENDED UP WITH A MYOPIC RESULT -1.00 -0.50 X 170 20/20 WITH AN INTRAOCULAR LENS (IOL). THE PATIENT EXPERIENCED BLURRY DISTANCE VISION. VISUAL ACUITY (VA) PRE-OPERATIVE (OP): 20/30, VA POST-OP: 20/60 -2. THEREFORE, THE LENS WAS EXPLANTED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND LOWER DIOPTER, 22.0) WAS IMPLANTED AS A REPLACEMENT. AT 3 WEEKS POSTOPERATIVE, THE PATIENT IS SEEING 20/25 -1 FOR DISTANCE AND 8 POINT NEAR AND INTERMEDIATE VISION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10544686 ↗
• InjurySep 4, 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 PATIENT¿S LEFT EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE THE PATIENT WAS EXPERIENCING BLURRY VISION, HALOS AND GLARE. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND A VITRECTOMY PERFORMED. NO SUTURES WERE REQUIRED. A REPLACEMENT LENS OF DIFFERENT MODEL, AR40E 22.5 DIOPTER WITH A DIFFERENT CARTRIDGE MODEL WERE USED. THERE WAS NO DELAY REPORTED. VISUAL ACUITY PRE-OPERATIVE: 20/70 UNCORRECTED, 20/40-2 CORRECTED NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Vitrectomy

  MAUDE report 10497080 ↗
• InjuryJun 29, 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 THE PATIENT BEING UNHAPPY WITH VISION. IT WAS NOTED THAT VISION BECAME BLURRY, BECAME MYOPIC. THE IOL WAS REPLACED WITH THE SAME MODEL, DIFFERENT DIOPTER, SUTURES WERE REQUIRED. THE PRE-OP VISUAL ACUITY (VA) WAS 20/50 AND POST OP VISION VA DAY ONE WAS 20/60. THERE WAS NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10210412 ↗
• 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 HER 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

  Patient problems: Halo; No Code Available

  MAUDE report 9804088 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT RIGHT EYE DUE TO EXCESSIVE GLARE. THERE WAS NO PATIENT SURGICAL ISSUE. THE REPLACEMENT LENS USED IS A NON-JOHNSON & JOHNSON VISION IOL. EXPLANT SURGERY WENT WELL AND PATIENT IS DOING FINE POST-OP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 9690340 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE PATIENT'S THREE (3) MONTH POST OP VISIT, (B)(6) 2019, THE PATIENT/SUBJECT STATED, YES, I AM BOTHERED BY STARBURSTS AND GLARE AT NIGHT. I HAVE NOT BEEN ABLE TO DRIVE BECAUSE OF MY NECK SURGERY BUT EVEN AS A PASSENGER I NOTICE THEM AND I WOULD BE AFRAID TO DRIVE. BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) - RIGHT EYE (OD) 20/25. BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) - LEFT EYE (OS) 20/20. BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) - BOTH EYES (OU) 20/20. FIRST EYE SURGERY (OD) (B)(6) 2019. SECOND EYE SURGERY (OS) (B)(6) 2019. NO FURTHER INFORMATION WAS PROVIDED. PATIENT HAS BILATERAL LENS IMPLANTS, THIS REPORT REPRESENTS THE LEFT EYE. A SECOND REPORT WILL BE SUBMITTED FOR THE RIGHT EYE.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9415757 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE PATIENT'S THREE (3) MONTH POST OP VISIT, (B)(6) 2019, THE PATIENT/SUBJECT STATED, YES, I AM BOTHERED BY STARBURSTS AND GLARE AT NIGHT. I HAVE NOT BEEN ABLE TO DRIVE BECAUSE OF MY NECK SURGERY BUT EVEN AS A PASSENGER I NOTICE THEM AND I WOULD BE AFRAID TO DRIVE. BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) - RIGHT EYE (OD) 20/25; BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) - LEFT EYE (OS) 20/20; BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) - BOTH EYES (OU) 20/20. FIRST EYE SURGERY (OD) (B)(6) 2019; SECOND EYE SURGERY (OS) (B)(6)2019. NO FURTHER INFORMATION WAS PROVIDED. PATIENT HAS BILATERAL LENS IMPLANTS, THIS REPORT REPRESENTS THE RIGHT EYE. A SECOND REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9415673 ↗
• InjuryOct 4, 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 +23.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING BLURRY/WAXY VISION. REPORTEDLY A LENS FROM ANOTHER MANUFACTURER WITH SAME DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. INCISION ENLARGEMENT WAS PERFORMED AND SUTURES WERE REQUIRED DURING THE PROCEDURE. VISUAL ACUITY PRE-OP WAS 20/20. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9158645 ↗
• InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXR00 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2018. DUE TO COMPLAINTS OF NOT BEING HAPPY WITH OD VISION AND WILL BE GETTING AN IOL EXCHANGE WITH ANOTHER PROVIDER. (B)(6) 2019 IT WAS REPORTED THE EXPLANTED LENS WAS NOT RETAINED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9149329 ↗
• InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXR00 INTRAOCULAR LENS (IOL) WAS EXPLANTED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL BUT LOWER DIOPTER (22.0). ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD HAZY VISION POST-OP AND WAS DIAGNOSED WITH ANISOMETROPIA. VISUAL DISTURBANCE WAS REPORTED. THERE WAS NO INCISION ENLARGEMENT AND THE PATIENT HAS RECOVERED.

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

  MAUDE report 8899639 ↗
• InjuryAug 14, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZXR00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO MECHANICAL FAILURE. THIS WAS REPORTED BY THE PATIENT AS CONSTANT HALOS AROUND LIGHTS DURING THE DAY AND AT NIGHT. THE HALOS HAD THE APPEARANCE OF A SPIDER WEB AROUND ALL LIGHT SOURCES. THESE SYMPTOMS COULD NOT BE RESOLVED WITH SPECTACLES. IT WAS NOTED THAT THERE WAS INCISION ENLARGEMENT. THE EXPLANTED IOL WAS REPLACED WITH A AAB00 IOL, POWER +23.00. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 8893543 ↗
• InjuryJul 31, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT PATIENT HAD SYMFONY NON-TORIC IMPLANTED AFTER THE CATARACT SURGERY ON (B)(6) 2019. REPORTEDLY THE SURGERY WENT UNEVENTFUL AND NEXT DAY THE VISUAL ACUITY WAS 20/20. 10 DAYS LATER, WHEN THE DOCTOR WAS GETTING READY TO PERFORM SECOND EYE, PATIENT REPORTED THAT SHE WAS TERRIBLE DISTANCE VISION, HOWEVER HER NEAR VISION IS GREAT. LENS WAS IN PERFECT POSITION, EYE TOTALLY QUIET. NO VISCOELASTIC BEHIND THE LENS OR ANYTHING ELSE AFFECTING THE POSITION. PATIENT WAS 20/80 SC (WITHOUT CORRECTION) AND J1. REFRACTION WAS BETWEEN -.50, -.75 20/20. SURGEON WAS SUPPOSEDLY GOING TO WAIT 3-4 WEEKS AND IF THE ISSUES WERE NOT RESOLVED A LENS EXCHANGE WAS A PROBABILITY. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +23.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE OF PATIENT EXPERIENCING POOR VISION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED DURING THE EXPLANT PROCEDURE. REPORTEDLY LENS WITH SAME MODEL AND LOWER DIOPTER OF 22.5 WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT WAS DOING WELL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 8845185 ↗
• InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED HER EXPERIENCE WITH THE SYMFONY LENSES SHE HAD IMPLANTED, (BOTH EYES) IN 2016. SHE CHOSE THE LENSES, RIGHT AFTER THEY RECEIVED FDA APPROVAL, BECAUSE THEY PROMISED SHE WOULD NOT NEED READING GLASSES. SHE REPORTS HER INTERMEDIATE AND DISTANCE VISION USED TO BE GOOD; NOT ANYMORE SINCE THE SURGERY. SHE HAD THE START OF CATARACTS AND WAS GOING TO HAVE LASIK; BUT DECIDED JUST TO GET THE LENSES INSTEAD. SHE HAS ALWAYS WORN READING GLASSES AND WANTED TO NOT HAVE TO WEAR THEM ANYMORE. SHE DID HAVE LASER SURGERY A FEW MONTHS AFTER THE LENSES WERE IMPLANTED; BUT IT DIDN'T REALLY HELP. THE DOCTOR RECOMMENDED OVER THE COUNTER DROPS TO HELP AS SHE REPORTED THAT ''SHE FEELS'' SOMETHING IN HER EYES. HER EYES HAVE BEEN REALLY BOTHERING HER OF LATE EVEN WITH THE DROPS. SHE DID GET PRESCRIPTION READING GLASSES. SHE IS RETIRED BUT WORKS ON A PROJECT BASIS. SHE CAN'T READ STREET SIGNS UNTIL SHE IS ON ''TOP'' OF THEM, SHE CAN FUNCTION AND DO DAILY ACTIVITIES; HOWEVER, HER VISION IS ALSO BLURRY. SHE CAN'T STAND THE ''HALOS''/CIRCLES. SHE HAS HAD MONOVISION MOST OF HER LIFE AND PRESBYOPIA. SHE DENIES ANY OTHER HEALTH CONDITIONS, NO GLAUCOMA, NO DIABETES, NO HYPERTENSION. SHE WILL BE S

  Patient problems: Blurred Vision; Foreign Body Sensation in Eye; Halo

  MAUDE report 8791130 ↗
• InjuryJun 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXR00 23.5 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 (22.0). THERE WAS NO INTERVENTION REQUIRED AND THE PATIENT WAS DOING WELL POST-EXCHANGE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8737692 ↗
• MalfunctionFeb 1, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A FOREIGN BODY WAS NOTICED UNDER THE INTRAOCULAR LENS IN THE CONTAINER. LENS WAS NEVER REMOVED FROM THE HOLDER. THIS WAS OBSERVED DURING HANDLING PRIOR TO INSERTION. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8298878 ↗
• InjuryJan 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT OUTCOME THREE-WEEKS POST IMPLANT OF A ZXR00 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS 20/25 J13. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING ZXR00 WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2018 AND THE LENS WAS EXPLANTED ON (B)(6) 2018 DUE TO COMPLAINT OF DIFFICULTY WITH DRIVING AT NIGHT. IT WAS ALSO REPORTED THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS INJURY, NO SUTURE(S), AND THERE WAS NO VITRECTOMY. THE PATIENT IS 20/20 IN BOTH EYES WITHOUT CORRECTION, SYMFONY IN OTHER, NON DOMINANT EYE, AND J5 AT NEAR IN SYMFONY EYE. THE PATIENT IS REPORTED TO BE HAPPY NOW. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8272963 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS SEEING WHITE LINE OR WAS HAVING POOR VISION AFTER THE IMPLANTATION OF MODEL ZXR00 TECNIS MULTIFOCAL IOL (INTRAOCULAR LENS) IN HER LEFT EYE. FURTHERMORE, SHE REPORTEDLY SAW A VERTICAL WHITE LINE MOSTLY CENTRAL AT ALL TIMES AS IT DOES NOT MOVE AND IT DOES NOT SHIMMER. THE PATIENT WAS INITIALLY IMPLANTED WITH A MONOFOCAL IOL (MODEL NOT PROVIDED) NEAR TARGET OF -2.25 RESULT ON (B)(6) 2018. THIS MONOFOCAL IOL WAS EXPLANTED AND EXCHANGED FOR A SYMFONY LENS ON (B)(6) 2018. AT EXCHANGE, THERE WERE NO SECONDARY INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURE REQUIRED. THERE WAS NO PATIENT INJURY. TO DATE, THE ZXR00 LENS REMAINS IMPLANTED. REPORTEDLY, THE OUTCOME OF THE EXCHANGE IS AFFECTING PATIENT'S DAILY ACTIVITIES. PATIENT'S BCVA (BEST CORRECT VISUAL ACUITY) PRE-SYMFONY LENS IMPLANT WAS 20/30 WITH PCO (POSTERIOR CAPSULE OPACIFICATION). PATIENT'S BCVA WITH SYMFONY, PRE-YAG LASER(YTTRIUM ALUMINIUM GARNET): 20/50. PATIENT'S BCVA WITH SYMFONY, POST-YAG LASER: 20/20. TARGET +0.01, OUTCOME WAS +0.25 + 0.50 X 070 20/20. NO ADDITIONAL INFORMATION PROVIDED.

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

  MAUDE report 8211370 ↗
• InjuryDec 28, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A ZXR00 INTRAOCULAR LENS WAS IMPLANTED ON (B)(6) 2018 AND REPOSITIONED ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8204084 ↗
• 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 IMPLANTED ON (B)(6) 2018 AND EXCHANGED FOR A ZCB00 IOL ON (B)(6) 2018. THE PATIENT IS DOING WELL AND VERY HAPPY WITH HER VISION. ADDITIONAL INFORMATION RECEIVED REVEALED THE IOL WAS EXPLANTED DUE TO NIGHT TIME COMPLAINT WITH DRIVING. THE PATIENT EXPERIENCED GLARE. THE INCISION WAS ENLARGED DURING THE IOL EXCHANGE AND A NEW JOHNSON AND JOHNSON IOL WAS IMPLANTED. NO VITRECTOMY WAS PERFORMED AND THE EXPLANTED LENS WAS THROWN OUT. NO ADDITIONAL INTERVENTION WAS PERFORMED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8192796 ↗
• InjuryNov 2, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT A ZXR00 23.5 DIOPTER LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE BECAUSE THE OPTIC OF THE LENS WAS NOTICED DISTORTED. REPORTEDLY, THERE WAS NO MEDICAL INTERVENTION REQUIRED AND THE PATIENT IS STABLE WITH NO INJURY. THE REPLACEMENT LENS WAS THE SAME MODEL AND DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8034188 ↗