TECNIS IOL ZXR00 (REF ZXR00U0225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 05050474579149), received between Nov 21, 2016 and Mar 2, 2026 — classified as 83 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED EXPERIENCING STARBURSTS IN THEIR VISION FOLLOWING THE IMPLANTATION OF PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENSES (IOLS). THE STARBURSTS ARE PARTICULARLY NOTICEABLE DURING NIGHTTIME DRIVING, ESPECIALLY IN THE PRESENCE OF MULTIPLE LANES OF HEADLIGHTS, AND THE USE OF YELLOW-TINTED LENS GLASSES HAS NOT MITIGATED THE ISSUE. THE PATIENT NOTED THAT THEIR VISION BECAME CLOUDY BETWEEN THE TIME OF THE LENS IMPLANTATION AND THE YTTRIUM-ALUMINUM-GARNET (YAG) LASER PROCEDURE AND WAS INFORMED THAT LENS EXCHANGE IS NOT AN OPTION AFTER UNDERGOING THE YAG PROCEDURE. NO ADDITIONAL ADVERSE EVENTS OR COMPLICATIONS WERE REPORTED APART FROM THE DESCRIBED VISUAL DISTURBANCE. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT UNDERWENT BILATERAL LENS IMPLANTATION. THIS REPORT PERTAINS TO THE LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Blurred Vision; Flashers

  MAUDE report 24492253 ↗
• InjurySep 6, 2023Adverse 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 AS THE PATIENT COMPLAINED OF HALOS, AND UNABLE TO DRIVE AT NIGHT. A NON-JOHNSON & JOHNSON REPLACEMENT LENS OF +21.0 DIOPTER WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. SUTURE INCISION USED, BUT NO VITRECTOMY OR INCISION ENLARGEMENT REQUIRED. THE PATIENT OUTCOME IS EXCELLENT, AND NO INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 17694367 ↗
• InjuryMay 4, 2023Adverse 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 GLARE AND HALO. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. IT WAS REPLACED WITH A DIB00, TECNIS SIMPLICITY EYHANCE LENS (22.5D). NO PATIENT POST-OP INJURY. PATIENT DOING BETTER POST-EXPLANT, HAS NOTICED LESS GLARE AND HALOS SINCE IOL EXCHANGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16873664 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IOL (INTRAOCULAR LENS) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO POOR VISION. THE SYMPTOMS WERE NOT DEBILITATING. THERE WAS NO CAPSULE TEAR, UNPLANNED VITRECTOMY OR SUTURES. NO MEDICATION OUTSIDE THE STANDARD OF CARE. THE REPLACEMENT LENS IS A NON JNJ MODEL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 16457512 ↗
• InjuryDec 13, 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 IMPLANTED IN A PATIENT'S RIGHT EYE. AFTER SURGERY (NO SPECIFIC DATE PROVIDED) THE PATIENT'S VISION WAS BLURRY AND LATER ON VISUAL ISSUES BECAME MORE BLURRY THEN WITH GLARE AND FLOATERS BECOMING WORSE. THE PATIENT STILL GOES TO WORK BUT HAS TO ADJUST THINGS SINCE SHE IS NOT ABLE TO DRIVE AT NIGHT ANYMORE. THE PATIENT WAS PRESCRIBED GLASSES WHICH SHE DID NOT MIND BUT HER ISSUE IS THE NOT BEING ABLE TO DRIVE AT NIGHT. SHE FEELS TERRIBLE AND IS TRULY AN UNHAPPY CAMPER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances; Vitreous Floaters

  MAUDE report 15974487 ↗
• InjuryDec 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 THE PATIENT'S LEFT EYE (OS) DUE TO BLURRY VISION FOR DISTANCE. THE PATIENT¿S PRE-OPERATIVE (OP) VISUAL ACUITY WAS 20/50 AND POST-OPERATIVE UNCORRECTED VISUAL ACUITY WAS 20/50-2. THE DIAGNOSTIC RX (PRESCRIPTION) WAS -1.00 -0.25 X 118 20/20. THERE WAS A NINE-MONTH DELAY IN SURGERY. ADDITIONAL SURGICAL INTERVENTIONS OF INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT'S SYMPTOMS WERE FIRST NOTED DURING A DILATED EXAM. DUE TO THE MYOPIC ENDPOINT, THE PATIENT ENJOYED 4PT READING VISION OS AND POSTPONED ANY INTERVENTION FOR NINE-MONTHS. ANOTHER JOHNSON & JOHNSON IOL (SAME MODEL, DIFFERENT DIOPTER OF 21.0) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT DEVELOPED A LARGE HYPHEMA ON DAY ONE POST-OP VISIT. ON THE SECOND DAY POST-OP VISIT, THE PATIENT HAD AN ANTERIOR CHAMBER WASH OUT. DUE TO THE COMPLICATIONS OF THE HYPHEMA AND ADDITIONAL SURGERY, THE PATIENT'S VISION ON DAY ONE POST-OP WAS COUNTING FINGERS 1 FOOT (CF1'), AND ON DAY TWO POST-OP DISTANCE VISION (DV) WAS 20/200 PINHOLE (PH) NO IMPROVEMENT (NI), POTENTIAL ACUITY METER (PAM) 20/60. NO ADDITIONAL INFORMATION WAS PROVIDE

  Patient problems: Blurred Vision; Hyphema; Visual Impairment

  MAUDE report 12986568 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING COMPLICATIONS WITH AN INTRAOCULAR LENS (IOL) SEEING STARBURSTS AND BIG RINGS AROUND LIGHTS IN THE LEFT EYE. WHEN THE PATIENT WAS DRIVING AT NIGHT, THE VISUAL ISSUES WERE SO DEBILITATING, SHE STOPPED DRIVING AFTER THAT. IT WAS LEARNED THAT THE LENS WAS EXPLANTED IN THE LEFT EYE A COUPLE WEEKS AGO. THE PATIENT DID NOT HAVE THE EXACT DATE. THE PATIENT DID NOT KNOW WHAT TYPE OF REPLACEMENT LENS WAS IMPLANTED AS A REPLACEMENT OR IF IT WAS A JOHNSON & JOHNSON LENS. THROUGH FOLLOW-UP WITH THE PATIENT'S IMPLANTING SURGEON'S OFFICE, IT WAS LEARNED THAT AT THE 1 MONTH POST-OPERATIVE (OP) VISIT, THE PATIENT COMPLAINED THAT SHE COULD NOT SEE CLEARLY. VISUAL ACUITY (VA) 20/50. ON (B)(6) 2020, THE PATIENT COMPLAINED OF HALOS AND SEEING CONCENTRIC CIRCLES THAT LOOK LIKE A FAN BLADE. VA 20/40-2. ON (B)(6) 2021, THE PATIENT STILL EXPERIENCED BLURRINESS AND COULD NOT SEE AT NIGHT. THE PATIENT TOLD THE SURGEON SHE NO LONGER DRIVES AT NIGHT AS THE PATIENT STILL SEES STARBURSTS AND BIG CIRCLES. THE SURGEON PRESCRIBED GLASSES AND ARTIFICIAL TEARS. THE PATIENT WAS SUPPOSED TO HAVE ANOTHER FOLLOW-UP APPOINTMENT, HOWEVER, THE PATIENT DECIDED TO SEE A DIFFER

  Patient problems: Blurred Vision; Flashers; Halo; Visual Disturbances

  MAUDE report 12492795 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT INDICATING THE INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO GLARES. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION SUCH AS INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 11249026 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAS BEEN COMPLAINING OF UNBEARABLE GLARE, HALO AND SHE IS UNABLE TO DRIVE AFTER THE IMPLANTATION OF THE TECNIS SYMFONY INTRAOCULAR LENS (IOL) IN HER RIGHT (OD) EYE. THE SURGEON PLANS TO DO A LENS EXCHANGE USING A NON-JOHNSON & JOHNSON IOL AS THE REPLACEMENT LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 10799122 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT REPORTED OF A PATIENT COMPLAINING ABOUT HALOS/ GLARE AROUND THE LIGHTS AT DUSK IN THEIR RIGHT EYE. THE DOCTOR SUSPECTS THAT IT MIGHT BE AN ERROR OF ANGLE KAPPA WHICH WAS NOTED AT THE POST-OP EXAMINATION AND ONLY ON THE RIGHT EYE OF THE PATIENT. THE DOCTOR IS CONSIDERING TREATMENT OPTIONS WHICH MAY BENEFIT THE PATIENT IN ADDITION TO INTRAOCULAR LENS EXCHANGE. THE LENS REMAINS IMPLANTED TO DATE. THE PATIENT WILL BE SEEN AGAIN MID AUGUST. THE DOCTOR HAD PRESCRIBED BRIMONIDINE OPHTHALMIC DROPS FOR THE DYSPHOTOPSIA AND WILL WAIT TO HEAR BACK AS TO IF THE PATIENT EXPERIENCED ANY IMPROVEMENT AND HAD NEUROADAPTATION. VISUAL ACUITY PRE-OPERATIVE: 20/30 BEST CORRECTED. VISUAL ACUITY POST-OPERATIVE: 20/20 BEST CORRECTED; 20/30 UNCORRECTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 10466913 ↗
• InjuryMay 19, 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 LEFT EYE DUE TO A REFRACTIVE MISS, AND PATIENT DISSATISFACTION. THERE WAS NO VITRECTOMY OR SUTURES REQUIRED. ANOTHER LENS (DIFFERENT MODEL AND HIGHER DIOPTER) WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10072999 ↗
• InjuryApr 2, 2020Adverse 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 RIGHT (OD) EYE ON (B)(6) 2020. IT WAS LATER EXPLANTED ON (B)(6) 2020 DUE TO REFRACTIVE MISS. THE PATIENT HAS HAD TWO (2) MULTIFOCAL LENSES EXPLANTED FROM HIS RIGHT EYE IN TWO SEPARATE SURGERIES WITHIN A MONTH. THE SURGEON DECIDED TO GO WITH A NON-JOHNSON AND JOHNSON MONOFOCAL (SINGLE FOCUS) LENS. AT EXCHANGE, THERE WAS NO INCISION ENLARGEMENT AND NO INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE EVENT FOR THE SECOND EXPLANTED LENS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE FIRST EXPLANTED LENS.

  Patient problems: No Code Available

  MAUDE report 9919207 ↗
• InjuryMar 13, 2020Adverse 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 RIGHT EYE DUE TO THE PATIENT EXPERIENCING GLARE, UNABLE TO DRIVE AT NIGHT, AND BLURRY DISTANCE VISION. DOCTOR MENTIONED THAT THE PATIENT HAD AN INTOLERANCE TO THE DIFFRACTIVE LENS WHICH WAS EXACERBATED BY VITREOUS OPACITIES. IT WAS ALSO STATED THAT VITRECTOMY WAS PERFORMED AND THE REPLACEMENT LENS IS A MODEL ZA9003 22.0 DIOPTER IOL. PATIENT OUTCOME IS REPORTED AS PATIENT IS HAPPY WITH VISION AND GLARE HAS RESOLVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Vitrectomy; Vitreous Floaters

  MAUDE report 9827912 ↗
• InjuryMar 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), MODEL ZXR00 WAS EXPLANTED FROM A PATIENT'S OPERATIVE EYE DUE TOR REFRACTIVE SURPRISE, POST-OP RESIDUAL REFRACTIVE ERROR. A REPLACEMENT LENS MODEL ZXR00 +19.50 DIOPTER WAS USED. THERE WERE SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE PATIENT OUTCOME AT THE TIME OF DISCHARGE WAS GOOD AND NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9784324 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING VISUAL DISTURBANCES. THE INTRAOCULAR LENS (IOL) IMPLANTED IN THE LEFT EYE WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON & JOHNSON LENS. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9650143 ↗
• InjuryDec 30, 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 RIGHT EYE DUE TO DYSPHOTOPSIA. NO ADVERSE EVENTS, NO PATIENT POST-OP INJURY. REPLACEMENT IOL WAS ZCB00 21.5 DIOPTER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9529517 ↗
• InjuryOct 3, 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 +22.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING POOR NIGHT VISION, WAXY AND GLARE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 9154419 ↗
• InjuryOct 1, 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 EXPLANTED DUE TO THE PATIENT EXPERIENCING VISUAL DISTURBANCE, UNEXPECTED POST-OPERATIVE REFRACTION, UNABLE TO FOCUS, AND UNABLE TO DRIVE AT NIGHT. THE LENS WAS DISCARDED. THERE WAS NO INCISION ENLARGEMENT OR ANY OTHER PATIENT INJURY REPORTED. ANOTHER LENS (DIFFERENT MODEL AND HIGHER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. REPORTEDLY, THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

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

  MAUDE report 9140988 ↗
• InjurySep 25, 2019Adverse 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 LEFT EYE DUE TO THE PATIENT BEING UNHAPPY WITH HER VISION. THE LENS WAS DISCARDED. THERE WAS NO INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY REQUIRED WHEN REMOVING THE LENS. THE LENS WAS SUCCESSFULLY REPLACED WITH A ANOTHER MODEL WITH A HIGHER DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS LEFT EYE.

  Patient problems: No Code Available

  MAUDE report 9121048 ↗
• InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXR00 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED AND REMOVED. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CLARIFYING THE PATIENT HAD A POSTERIOR POLAR CATARACT AND AFTER THE ZXR00 LENS WAS INSERTED, THERE WAS A POSTERIOR CAPSULAR RUPTURE. THE ZXROO WAS REMOVED AND A NON-JJSV 3-PIECE LENS WAS INSERTED. THERE WERE NO SUTURES OR COMPLICATIONS AND NO VITRECTOMY. CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING NO INCISION ENLARGEMENT, PATIENT OUTCOME REPORTED AS GOOD, AND THE LENS IS NOT BEING RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Capsular Bag Tear

  MAUDE report 8963398 ↗
• InjuryJul 19, 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 PATIENTS LEFT EYE. THE PATIENT WAS UNABLE TO DRIVE AT NIGHT DUE TO COMPLAINT OF GLARE AND VISUAL DISTURBANCE; PATIENT UNABLE TO FOCUS. THE EXPLANTED IOL WAS REPLACED WITH ANOTHER LENS OF THE SAME MODEL BUT DIFFERENT DIOPTER. THERE WAS NO PATIENT HARM, NO INJURY AND NO INCISION ENLARGEMENT. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

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

  MAUDE report 8808769 ↗
• InjuryJul 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS NOT HAPPY WITH THE INTRAOCULAR LENS BECAUSE OF POOR VISION. THEREFORE, THE LENS WAS EXPLANTED. VISUAL ACUITY PRE-OP: 20/50 +1 AND VISUAL ACUITY POST-OP: 20/80 +1. AT EXPLANT, THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8796587 ↗
• 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 8791163 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXR00 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE IOL WAS EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINT OF BLURRY VISION. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING REPORTED BLURRY VISION WAS FIRST REPORTED/OBSERVED (B)(6) 2019, AND AFFECTS DRIVING, READING, AND REPORTED AS DEBILITATING. AT EXPLANT THERE WERE NO COMPLICATIONS, SUCH AS CAPSULAR TEAR, INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. NO PATIENT INJURY REPORTED. THE REPLACEMENT LENS IS A MODEL ZCB00 26.5 DIOPTER LENS. THE PATIENT WAS REPORTED AS DOING WELL AT DAY ONE POST-EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

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

  MAUDE report 8779120 ↗
• InjuryJul 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A ZXR00 22.5 DIOPTER INTRAOCULAR LENS (IOL) IMPLANTED IN THE PATIENT'S LEFT (OS) OPERATIVE EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO UNEXPECTED REFRACTIVE OUTCOME. THERE WAS NO COMPLICATIONS REPORTED DURING POSTOP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8770052 ↗