TECNIS IOL ZXR00 (REF ZXR00U0155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 05050474591752), received between Nov 28, 2016 and Jan 6, 2022 — classified as 27 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED ON A JOHNSON AND JOHNSON SOCIAL MEDIA ACCOUNT THAT AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS), THE LENS "DE-CENTERED ITSELF." THE PATIENT IS NOT ABLE TO "SEE NEAR OR FAR." THE PATIENT REPORTED NOW HAVING TO SEE A RETINA SPECIALIST AND GO THROUGH A LONG SURGERY. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP WITH THE PATIENT, IT WAS LEARNED THAT THE SYMPTOMS OF BEING UNABLE TO FOCUS OS BEGAN IMMEDIATELY AFTER SURGERY. THE PATIENT NOTED, "IT WAS NOT BLURRY, BUT COULD NOT FOCUS" AND CANNOT "SEE NEAR OR FAR." WHEN THE PATIENT RETURNED TO THE DOCTOR TWO DAYS LATER, THE OS WAS DILATED AND IT WAS NOTICED THAT THE IOL WAS DISLOCATED TO THE RIGHT NASALLY. THE PATIENT REPORTED THAT ¿THE CATARACT SEEMED MORE DIFFICULT TO REMOVE" AND THE SURGERY SEEMED TO "GO DIFFERENTLY" THEN HOW IT WENT WITH THE RIGHT EYE, WITH WHICH THERE WAS NO ISSUES. THE DOCTOR DID NOT PROVIDE THE PATIENT WITH ANY INFORMATION REGARDING ANY ISSUES DURING OR AFTER SURGERY. THE PATIENT REPORTED THAT THERE WERE NO SURGICAL INTERVENTIONS OR INJURY TO THE EYE THAT THE PATIENT IS AWARE OF AND THE PATIENT DID NOT DEVELOP ANY INFECTION. THERE HAS BEEN NO TRAUMATIC INJURY TO THE EYE.

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

  MAUDE report 13173882 ↗
• InjuryAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIALLY, THE CUSTOMER REPORTED THAT POST-IMPLANT OF THE INTRAOCULAR LENS (IOL) IN THE PATIENT'S LEFT EYE, THERE WAS REFRACTIVE SURPRISE. THE DOCTOR PLANNED ON EXPLANTING THE IOL. FURTHER INFORMATION WAS RECEIVED. THE CUSTOMER EXPLAINED THAT THE PATIENT WAS EXPERIENCING BLURRY VISION AT BOTH DISTANCE AND NEAR. POST-OP MANIFEST REFRACTION (PO MRX) + 0.75 SPH (SPHERE). PRE-OP HAND MOTION (HM) @ FACE. VISUAL ACUITY POSTOP 20/40 -1. ON (B)(6) 2020, THE CUSTOMER CONFIRMED THAT THE IOL WAS EXPLANTED (B)(6) 2020. THE REPLACEMENT LENS IS A DIFFERENT MODEL ZA9003, AND HIGHER DIOPTER 21.0. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND NO VITRECTOMY REQUIRED. REPORTEDLY, THE PATIENT IS DOING OK POST-EXCHANGE AND IS VERY HAPPY. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 10405446 ↗
• InjuryMay 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS. THE PATIENT IS EXPERIENCING LIGHT SENSITIVITY, AND HALOS AT NIGHT. ADDITIONALLY, WHEN USING THE COMPUTER, THE PATIENT EXPERIENCES DIZZINESS AND FLUTTER. THE PATIENT EXPLAINED THAT HIS SYMPTOMS ARE IN BOTH EYES AND THEY BEGAN IN LATE (B)(6) 2020. FOLLOW-UP IT WAS LEARNED THE PATIENT IS NOT TAKING ANY MEDICATION FOR HIS SYMPTOMS. THE PATIENT¿S EYES ARE LIGHT BLUE. THE PATIENT EXPLAINED THAT HE HAS ALWAYS BEEN SENSITIVE TO LIGHT EVEN BEFORE THE IOLS WERE IMPLANTED. PRIOR TO THE LENS IMPLANTS, LIGHT FROM HIS BEDROOM WINDOW BOTHERED HIM EVEN WITH HIS EYES CLOSED. HE MUST PUT A PILLOW OVER HIS FACE. HE CAN¿T WATCH TELEVISION IN THE DARK, HE MUST TURN ON ALL THE LIGHTS. ALSO, WHEN HE WORKS ON HIS COMPUTER AND THEN GETS UP AND GOES TO THE KITCHEN, THE LIGHTS IN THE KITCHEN MAKE HIM DIZZY. HE HAS LED LIGHTS THROUGHOUT HIS HOUSE WHICH HE NOW TURNS ALL THE WAY DOWN, THAT HELPS A LITTLE BIT. HIS LIGHT SENSITIVITY IS ABOUT 50% MORE THAN IT WAS BEFORE AND IS IMPACTING HIS DAILY LIFE. HOWEVER, THE PATIENT REPORTS HE IS VERY HAPPY WITH HIS EYESIGHT AND HIS EYESIGHT IS GOOD. THE FLUTTERING IN HIS EYES HAPPENS

  Patient problems: Dizziness; Halo; Visual Disturbances

  MAUDE report 10090551 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT WAS IMPLANTED BILATERAL INTRAOCULAR LENSES FOR CATARACT. FOR THE LEFT EYE (OS), ZXR00 WAS IMPLANTED. THEN FOR THE RIGHT EYE (OD), ZXT150 WAS IMPLANTED. SOON AFTER BOTH IMPLANTS, THE PATIENT DEVELOPED VISUAL ISSUES. HIS CONCERNS ARE THAT HIS EYES ARE TIRED AND REPEATEDLY ATTEMPT TO CLOSE AFTER 5 PM. ALSO, HIS EYES FEEL DRY, ALSO A LATE AFTERNOON OBSERVATION. BOTH EYES TEAR FREQUENTLY, MORE AT EVENING BUT THROUGHOUT THE DAY. THE SENSATION OF LOOKING THROUGH FRAMES, AS IF USING BINOCULARS. HIS READING VISION IS WORSE THAN IT HAS EVER BEEN. HE HAD ANTICIPATED NOT WEARING GLASSES. THE DARK SPOTS CONTINUE TO SHOW UP OCCASIONALLY, BUT THEY ARE REDUCED IN FREQUENCY. IT WAS LEARNED THROUGH FOLLOW-UP THAT HE HAD YTTRIUM-ALUMINUM-GARNET LASER TREATMENT (YAG) TO REMOVE CELL GROWTH. THE PATIENT MENTIONED THAT HE HAS DRY EYES AND IT MAKES HIS EYES FEEL LIKE THEY HAVE SAND IN THEM AND HIS EYES TEAR. OVER THE COUNTER EYE DROPS WERE PROVIDED BY THE DOCTOR FOR THE DRY EYE SYMPTOMS. THE DROPS HAVE HELPED BUT HAVE NOT ELIMINATED THE SYMPTOMS. HIS DOCTOR HAD NO PLAN TO EXPLANT AND PROVIDED HIM A LETTER INDICATING THAT HIS RESULTS FALL WITHIN THE PARAMETERS OF A SUCCE

  Patient problems: Dry Eye(s); Excessive Tear Production; Visual Impairment

  MAUDE report 9782001 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL), MODEL ZXR00 15.5 DIOPTER WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT EYE DUE TO SPHERE HALOS AND SOMETHING TO DO WITH READERS WHICH THE PATIENT FELT LIKE SHE WAS LOOKING THROUGH COTTON CANDY. IT WAS INDICATED THAT THE LENS WAS IMPLANTED AT ANOTHER LOCATION ON (B)(6) 2019. A NON JOHNSON & JOHNSON LENS OF 15.0 DIOPTER WAS USED AS REPLACEMENT. THERE WERE NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. REPORTEDLY, THE PATIENT IS DOING WELL POST-OP AND NO PATIENT INJURY WAS REPORTED. IT WAS NOTED THAT THE PRODUCT WILL NOT BE RETURNED AS IT WAS THROWN AWAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9778769 ↗
• InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED FROM A MALE PATIENT WHO HAD INTRAOCULAR LENSES IMPLANTED IN BOTH EYES ONE (1) YEAR AGO. HE REPORTS THAT VISION IN THE LEFT EYE (OS) IS POOR AND HIS EYE HURTS. THE PATIENT ALSO EXPERIENCES DISCOMFORT, THAT AFTER A FEW HOURS OF WORKING ON THE COMPUTER, HE FEELS AN ACHE IN THE BACK OF HIS EYES AND MUST USE A PATCH OVER THE EYE AFTER A FEW HOURS. THE PATIENT INDICATED THAT HE IS USING EYE DROPS FOR LUBRICATION BUT IT DOES NOT HELP. REPORTEDLY, THE POOR NEAR VISION IS MOST NOTICEABLE. THE PATIENT WAS REFERRED TO A DIFFERENT DOCTOR FOR A SECOND OPINION AND WAS TOLD HE HAS ASTIGMATISM. THE PATIENT WAS SUPPOSED TO HAVE VISION CORRECTED TO 20/25, BUT THE SECOND OPINION REPORTED 20/40. THE PATIENT THINKS HE SHOULD HAVE HAD A TORIC MONOFOCAL LENS INSTEAD OF THE MULTIFOCAL TECNIS SYMFONY WHICH HE CURRENTLY HAS IMPLANTED IN HIS LEFT EYE. THE PATIENT USES GLASSES WHICH HE DID NOT WANT TO WEAR IN THE FIRST PLACE, USES COMPUTER AND DOES HIS DAILY ACTIVITIES BUT REPORTEDLY, HE ENDS UP WITH ACHES AND PAIN. THE PATIENT FEELS THAT THE DOCTOR PUT IN A LENS THAT WAS NOT COMPATIBLE WITH ASTIGMATISM WHICH HE THINKS HE HAD THIS CONDITION BEFORE THE SURGERY. THE PATIENT HAD THE RIGHT E

  Patient problems: Discomfort; Pain; Visual Impairment

  MAUDE report 9723279 ↗
• InjuryJan 8, 2020Adverse 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 RIGHT EYE DUE TO DYSPHOTOPSIA. THERE IS NO INJURY OR INTERVENTION PERFORMED. PATIENT IS DOING FINE POST-OP. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9567052 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE 1-MONTH CLINICAL STUDY VISIT THE PATIENT WAS BOTHERED BY HALOS AND STARBURSTS CAUSING DIFFICULTY WHILE DRIVING. BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA). ADDITIONAL INFORMATION RECEIVED FROM THE 6-MONTH CLINICAL STUDY VISIT REPORTED THAT PATIENT NOTED BEING BOTHERED BY HALOS AND STARBURSTS. THE SYMPTOMS DO INTERFERE WITH DAILY ACTIVITIES (DRIVING). UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA). THE IOL REMAINS IMPLANTED IN THE SUBJECT EYE WITH NO INTERVENTION PLANNED. THIS MDR IS FOR THE LEFT EYE. A SEPARATE MDR IS BEING SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 8800760 ↗
• InjuryMar 31, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF A MODEL, ZXR00 MULTIFOCAL IOL (INTRAOCULAR LENS) INTO THE PATIENT'S RIGHT EYE (OD) THERE WAS A MODERATE MECHANICAL COMPLICATION OF THE LENS, AS THE PATIENT EXPERIENCED SIGNIFICANT GHOSTING. REPORTEDLY, THIS OUTCOME SIGNIFICANTLY INTERFERED WITH THE PATIENT¿S DAILY ACTIVITIES. AS A RESULT, THE LENS WAS EXPLANTED, AND THE PATIENT WAS REPORTED AS RECOVERED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8467972 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HYPEROPIC MISS OF 0.5 OFF NEAR VISION AFTER THE IMPLANTATION OF LENS MODEL, ZXR00 MULTIFOCAL IOL (INTRAOCULAR LENS) IN HIS RIGHT EYE (OD). AS A RESULT, LENS WAS EXPLANTED AND REPLACED WITH THE SAME MODEL, A 17.0 DIOPTER LENS. IT WAS ALSO NOTED THAT PATIENT IS DOING FINE POST OP. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8376630 ↗
• InjuryJan 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018 DUE TO EITHER REFRACTIVE ERROR OR DYSPHOTOPSIA. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8251454 ↗
• InjurySep 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SHE HAD A MODEL ZXR00 15.5 DIOPTER INTRAOCULAR LENS (IOL) IMPLANTED (B)(6) 2018. ((B)(6) 2018). PATIENT FEELS THAT THE IOL HAS NOT DONE WHAT IT WAS SUPPOSED TO. SHE IS STILL HAVING TO WEAR GLASSES ALL THE TIME WHEN SHE WAS TOLD SHE WOULDN¿T HAVE TO, AND SHE EXPERIENCES STARBURSTS AT NIGHT TO THE POINT WHERE SHE IS UNABLE TO DRIVE AT NIGHT ANYMORE. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT HAS BILATERAL LENS IMPLANTS. THIS REPORT REPRESENTS THE LENS WITH SERIAL NUMBER (B)(4).

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7908362 ↗
• InjurySep 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SHE HAD A MODEL ZXR00 15.5 DIOPTER INTRAOCULAR LENS (IOL) IMPLANTED (B)(6) 2018. PATIENT FEELS THAT THE IOL HAS NOT DONE WHAT IT WAS SUPPOSED TO. SHE IS STILL HAVING TO WEAR GLASSES ALL THE TIME WHEN SHE WAS TOLD SHE WOULDN¿T HAVE TO, AND SHE EXPERIENCES STARBURSTS AT NIGHT TO THE POINT SHE IS UNABLE TO DRIVE AT NIGHT ANYMORE. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT HAS BILATERAL LENS IMPLANTS. THIS REPORT REPRESENTS IOL WITH SERIAL NUMBER (B)(4).

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7908361 ↗
• InjurySep 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING BLURRED VISION AT BOTH DISTANCE AND NEAR AND DEPTH PERCEPTION WAS OFF TOO. PATIENT WAS UNHAPPY AND COULD NOT FUNCTION DUE TO POOR VISION. THESE SYMPTOMS SIGNIFICANTLY INTERFERED WITH ACTIVITIES OF DAILY LIFE. THE LENS WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS. THERE WAS NO PATIENT INJURY. THE PRODUCT WAS DISCARDED BY THE SURGERY CENTER. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT PERTAINS TO RIGHT EYE (OD).

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7900325 ↗
• InjuryAug 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DOCTOR REPORTED THAT A PATIENT WHO WAS IMPLANTED WITH A SYMPHONY LENS HAS POOR VISION, AND A FINAL SPHERICAL EQUIVALENT OF -1.75. REPORTEDLY, SINCE THE LOW POWER SILICONE 3 PIECE LENSES ARE NOT MADE ANY LONGER, THE DOCTOR REPORTED HE WOULD NEED TO DO AN EXPLANT OF THE LENS. IT WAS INDICATED THAT THE OPTIWAVE REFRACTIVE ANALYSIS SYSTEM (ORA) PREDICTED THIS LENS POWER TO YIELD EMMETROPIA, BUT PATIENT REFRACTS TO A SPHERICAL EQUIVALENT OF -1.75 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 7774893 ↗
• InjuryJul 30, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXR00 15.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED BECAUSE THE PATIENT HAD DECREASED VISUAL ACUITY. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 18.0. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7733170 ↗
• InjuryMar 27, 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, +15.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE IN A SECONDARY PROCEDURE BECAUSE THE PATIENT WAS UNABLE TO FOCUS WITH THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7375920 ↗
• InjuryMar 5, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +15.5 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE FROM PATIENT'S OPERATIVE EYE BECAUSE OF AN UNSPECIFIED LENS MALFUNCTION DIAGNOSIS. REPORTEDLY A MODEL ZXR00, WITH A SMALLER DIOPTER OF +14.5 WAS IMPLANTED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS DOING GOOD WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7315099 ↗
• InjuryMar 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED THAT A ZXR00 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S LEFT EYE (OS) AS THE PATIENT WAS UNABLE TO SEE CLEARLY THROUGH THE MULTI FOCAL SYMFONY IOL, AND CORRECTION BY SPECTACLES DID NOT RESOLVE THE VISUAL BLUR. A NEW INCISION WAS MADE AND THE INCISION WAS ENLARGED TO REMOVE THE IMPLANTED LENS IN WHOLE. THE ZXR00 LENS WAS REPLACED WITH A MONOFOCAL LENS AND REPORTEDLY, THE PATIENT IS APPRECIATING IMPROVED VISION QUALITY AS DEMONSTRATED AT THE ONE (1) DAY POST OPERATIVE EXAM. THERE WAS NO VITRECTOMY PERFORMED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 7310829 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO VISION PROBLEMS. THERE WAS NO VITRECTOMY REQUIRED. THE REPLACEMENT LENS WAS A NON-AMO LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7162614 ↗
• InjuryDec 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE LEFT EYE (OS) OF THE PATIENT ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO PATIENT COMPLAINING OF NIGHT TIME VISUAL DISTURBANCE. THE PATIENT DESCRIBED VISION AS LOOKING THROUGH VASELINE. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. THE LENS WAS REPLACED WITH A ZCBOO IOL OF THE SAME DIOPTER. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING WELL WITH NO POST-OPERATIVELY COMPLICATION.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7153736 ↗
• InjuryNov 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OD) OF THE PATIENT. THE PATIENT COMPLAINED OF SEVERE GLARE AND VISION LOSS. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7004758 ↗
• InjuryAug 28, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZXR00 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO AN UNSPECIFIED LENS MALFUNCTION. THE LENS WAS REPLACED WITH THE SAME MODEL OF A LOWER DIOPTER (14.0) LENS. IT WAS REPORTED THAT THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6825316 ↗
• InjuryAug 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXPLANT OF A TECNIS SYMFONY INTRAOCULAR LENS (IOL), MODEL ZXR00 15.5 DIOPTER DUE TO REFRACTIVE ERROR FROM PRESBYOPIA. THE EXPLANTED LENS WAS REPLACED WITH A MODEL ZLB00 16.5 DIOPTER LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6806231 ↗
• InjuryMay 9, 2017Material Opacification; Appropriate Device Problem Term/Code Not Available; Material Opacification; Appropriate Device Problem Term/Code Not Available

  A MALE PATIENT INITIALLY REPORTED THAT HE IS HAVING ISSUES WHEN HE LAYS DOWN, OR WHEN HE RECLINES. HE STATED HE LOSES HIS READING ABILITY AND HIS DOCTOR IS NOT SURE WHAT THE CAUSE CAN BE. THROUGH FOLLOW UP WITH THE PATIENT IT WAS FURTHER CLARIFIED THAT THE ISSUE ONLY OCCURS WHEN HE LEANS BACK OR LAYS DOWN. HE ALSO REPORTED BEING ABLE TO SEE THE CIRCLE ON THE LENS ESPECIALLY AT DUSK AND AT NIGHT. WHEN ASKED IF THEY WERE AN ISSUE, HE STATED IT WAS A DISTRACTION. HE IS SCHEDULED THIS WEEK TO HAVE A CAPSULOTOMY. THE BACK OF HIS LENS IS PARTLY CLOUDY AND THE DOCTOR WILL USE A YAG (YTTRIUM ALUMINIUM GARNET) LASER TO MAKE A HOLE IN THE LENS TO CLEAR UP HIS VISION. THE LENS WAS INSERTED IN HIS RIGHT EYE. FOLLOW UP WITH THE CLINIC WAS CONDUCTED. THERE ARE NO PLANS TO REMOVE THE LENS BUT A YAG CAPSULOTOMY WAS PERFORMED ON (B)(6) 2017. PATIENT SEEMS OK AFTER THE YAG CAPSULOTOMY. NEXT FOLLOW-UP WILL BE IN (B)(6). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 6555900 ↗