TECNIS IOL ZXR00 (REF ZXR00U0220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 05050474579132), received between Dec 23, 2016 and Mar 2, 2026 — classified as 82 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (6 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 89 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 RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Flashers

  MAUDE report 24492248 ↗
• InjuryMay 26, 2024Adverse 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 SINCE THE PATIENT WAS UNABLE TO ADAPT TO THE LENS. THE ISSUE WAS IDENTIFIED DURING POST-OP EXAMINATION. A REPLACEMENT LENS OF DIFFERENT MODEL AND DIOPTER (ZCB00, +21.5D) WAS USED. NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 19399110 ↗
• InjuryNov 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZXR00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S OPERATIVE EYE. IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXCHANGED FOR ANOTHER IOL WITH THE SAME MODEL BUT DIFFERENT DIOPTER SIZE, ZXR00 20.5 DIOPTER IOL; REASONS FOR THE EXPLANT WERE NOT PROVIDED. PATIENT OUT-COME POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 18070426 ↗
• InjurySep 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE. THE IOL SUBLUXED, DECENTERED TEMPORARILY AFTER IT WAS IMPLANTED. THE DOCTOR EXPLANTED THE LENS AND REPLACED IT WITH A NON-JNJ IOL. THERE WERE NO OTHER COMPLICATIONS OR HARM TO THE PATIENT. THE BACKUP IOL WAS USED SUCCESSFULLY. REPORTEDLY, THERE WAS NO VITRECTOMY OR SUTURE REQUIRED. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17733876 ↗
• InjuryMar 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD BILATERAL LENS IMPLANTS, AFTER THE SURGERY EXPERIENCED PAIN IN EYE WHICH FELT LIKE WOOD IN THEIR EYES. IT WAS ALSO REPORTED THERE WAS DRYNESS WITH A BLURRY SCALY FEELING. FOR MONTHS, THE PATIENT WAS UNABLE TO DRIVE AT NIGHT BECAUSE OF GLARE AND DECREASED EYESIGHT. THE PATIENT WAS DIAGNOSED WITH SIGNIFICANT POSTERIOR CAPSULAR OPACIFICATION (PCO) AND TREATED WITH YTTRIUM-ALUMINUM-GARNET (YAG) LASER CAPSULOTOMY IN THE LEFT EYE (OS). THE RIGHT EYE (OD) IMPLANT WAS EXPLANTED DUE TO MECHANICAL COMPLICATIONS OF THE INTRAOCULAR LENS (IOL). FURTHER REVIEW OF THE PATIENT CHART NOTED THAT THE EVENT STARTED AS BILATERAL CATARACT EXTRACTION. THE LEFT EYE WAS IMPLANTED FIRST, WITH INITIAL DIAGNOSIS OF CATARACT, DRY EYE SYNDROME AND OPEN ANGLE GLAUCOMA. AT 1-DAY POST-IMPLANT, VISION WAS POOR BUT FAIRLY STABLE, DULL HEADACHE BUT WENT AWAY. 2ND DAY POST-OP, NO IMPROVEMENT, THEREFORE, THE PATIENT WAS CONCERNED. ABOUT 10 DAYS POST-IMPLANT PATIENT COMPLAINED OF FOREIGN BODY SENSATION/BLURRY VISION; BUT DESCRIBED THEIR VISION AS FAIRLY STABLE. AT ABOUT MORE OR LESS 2 MONTHS POST-IMPLANT, IN RELATION TO THE LEFT EYE, THE PATIENT COMPLAINS OF RECENT ONSET OF STARBUR

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Flashers; Foreign Body Sensation in Eye; Halo; Pain

  MAUDE report 16570073 ↗
• InjuryMar 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE IOL (INTRAOCULAR LENS) WAS EXPLANTED BECAUSE IT DISLOCATED, AND THE PATIENT WAS EXPERIENCING BLURRY VISION. REPORTEDLY, THE PATIENT DID NOT HAVE A PREVIOUS LASIK PROCEDURE THAT MIGHT HAVE AFFECTED THE OUTCOME OF THIS PROCEDURE. ADDITIONALLY, THERE WERE NO DEBILITATING SYMPTOMS REPORTED. THE REPLACEMENT LENS IS THE SAME MODEL AND DIOPTER. THERE WERE NO PATIENT INJURIES SUCH AS CAPSULE TEAR, INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THE EXPLANTED IOL WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16569982 ↗
• InjuryDec 14, 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 FROM THE PATIENT'S RIGHT EYE AFTER 2 YRS. OF EVALUATION. PATIENT UNABLE TO ADAPT TO LENS GLARE AND WEBBING. IT WAS INDICATED THAT THE PATIENT¿S DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. PRE-OP VISION 20/25 CC. POST-OP VISION 20/15 CC. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY DONE. THE EPLACEMENT IOL WAS A NON JOHNSON AND JOHNSON IOL, SAME DIOPTER SIZE AS ORIGINAL IOL. THE PATIENT FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances; Vitreous Floaters

  MAUDE report 15981289 ↗
• InjuryOct 11, 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 FROM THE PATIENT'S LEFT EYE BECAUSE PATIENT WAS UNABLE TO ADAPT TO SUSPECT IOL. THIS WAS REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS, MODEL ZA9003 +21.5 D. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY NO SUTURES PERFORMED. IT WAS STATED THAT THE PATIENT FULLY RECOVERED POST-EXPLANT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 15584853 ↗
• MalfunctionSep 2, 2022Material Opacification; Material Opacification

  A DOCTOR REPORTED THAT A PATIENT WHO WAS IMPLANTED WITH A SYMFONY INTRAOCULAR LENS (IOL) LAST MONTH ON (B)(6) 2022 ENDED UP A -1.50. THIS WAS THE PATIENT'S SECOND EYE AND THE CALCULATIOS WERE VERY SIMILAR TO WHEN THE PATIENT'S FIRST EYE WAS DONE A FEW YEARS AGO BY ANOTHER DOCTOR. THE DOCTOR ALSO INDICATED THAT THE LENS HAS SOME UNUSUAL CENTRAL HAZE THAT IS VERY CIRCULAR AND CONFINED TO THE FIRST RING, THAT IT IS NOT CAPSULE. THE DOCTOR IS PLANNING ON EXCHANGING THE LENS BEING CONCERNED THAT IT COULD CAUSE FUTURE VISUAL ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 15344074 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A FAMILY FRIEND THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE PATIENT EXPERIENCED CLOUDY VISION IN THEIR RIGHT EYE. THE PATIENT VISITED THE DOCTOR ABOUT THE CLOUDY VISION, BUT NO OTHER INFORMATION WAS KNOWN BY THE REPORTER. THROUGH FOLLOW-UP WITH THE FAMILY FRIEND ON (B)(6) 2022, IT WAS LEARNED THAT THE PATIENT IS UNABLE TO SEE OUT OF THE EYE AT ALL. IT WAS REPORTED THAT THE PATIENT HAS NEVER BEEN ABLE TO SEE OUT OF IT SINCE THE SURGERY. THIS ISSUE IS NOT ABLE TO BE CORRECTED WITH GLASSES. THE PATIENT IS SUPPOSED TO BE GOING TO ANOTHER DOCTOR SOMETIME SOON. THE PATIENT HAS BEEN BACK AND FORTH TO THE DOCTOR AND WAS TOLD THAT THERE IS NOTHING THAT CAN BE DONE. THE REPORTER NOTED THAT THE DOCTOR "TRIED TO DO SOMETHING TO CLEAR IT", BUT WAS UNABLE TO SPECIFY ANY FURTHER. THERE ARE NO PLANNED INTERVENTIONS AT THIS TIME. THE IOL REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 15200566 ↗
• InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT REPORTED THAT HE HAD BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS IN (B)(6) 2019 AND (B)(6) 2019 AND SINCE THEN, THE PATIENT FEELS THAT SOMETHING IS NOT RIGHT. WHEN THE PATIENT FIRST GOT THE PROCEDURE DONE, HIS VISION WAS NOT AS GOOD AS HE EXPECTED, HOWEVER, THE PATIENT IS NOT SEEING AS WELL, AS HE FIRST DID IN 2019. THE PATIENT INDICATED THAT RIGHT AFTER THE SURGERIES, HE STARTED HAVING BLURRY VISION AND RECENTLY HE IS ALSO HAVING FLOATERS AND SPIDER WEBS. THERE ARE MULTIPLE FLOATERS IN HIS LEFT EYE THAT ARE BOTHERSOME. THE PATIENT CANNOT SEE HIS DAILY TOILETRIES AND HE CANNOT SEE WHEN HE SHAVES ANYMORE. THE PATIENT MENTIONED THAT HE HAD VERY DRY EYES, THAT THEY WERE DRY BEFORE BUT MORE SO NOW. THE PATIENT HAS BEEN USING SOME SORT OF LUBRICANT EVERY TWO (2) HOURS AND HAS ALSO BEEN GIVEN RESTASIS EYE DROPS WHICH HE USES TWICE A DAY. THE PATIENT FEELS THAT HIS EYES ARE BETTER WHEN HE USES THE LUBRICANT DROPS. THE PATIENT WAS TOLD HE CAN USE OVER THE COUNTER READERS, BUT SOMETIMES 1.25 DIOPTER (D) WORKS FOR HIM AND SOMETIMES IT DOES NOT WHICH THEN, HE HAS TO USE A DIFFERENT POWER, 1.5 D. THE PATIENT HAS SEEN HIS DOCTOR AS WELL AS ANOTHER DOCTOR AT THE SAME OFFICE FOR A SE

  Patient problems: Blurred Vision; Vitreous Floaters

  MAUDE report 12989061 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT NOTICED SYMPTOMS ONE WEEK POST-IMPLANT OF A MODEL ZXR00 INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD). SYMPTOMS REPORTED WERE STARBURSTS, HAZE, AND BLURRY VISION. THE LENS WAS SUBSEQUENTLY EXPLANTED DUE TO DIFFRACTIVE LENS INTOLERANCE, MILDLY MYOPIC, AND SOME ASTIGMATISM WITH SIGNIFICANT FLOATERS. A PARS PLANA VITRECTOMY WAS PERFORMED. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, AND NO INJURY REPORTED. THE EXPLANTED LENS WAS DISCARDED AND THE REPLACEMENT LENS IS A NON-JOHNSON & JOHNSON IOL. POST-EXCHANGE THE PATIENT'S VISION IS GOOD AND REALLY CLEAR, STARBURSTS HAVE RESOLVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Flashers; Insufficient Information; Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 11873858 ↗
• InjuryDec 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 A CORRECTION ISSUE. REFRACTION WAS NOT SATISFACTORY. SUSPECT PRODUCT WAS DISCARDED IN FACILITY. IT WAS REPLACED WITH A SAME MODEL, LOWER DIOPTER SIZE (21.0) IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 11085583 ↗
• MalfunctionDec 28, 2020Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS FULLY INSERTED AND REMOVED SUCCESSFULLY WITH BACK UP LENS IMPLANTED DUE TO BENT HAPTIC WHILE LOADING. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11084899 ↗
• InjuryDec 17, 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 PATIENT SEEING HALOS AND CANNOT DRIVE AT NIGHT. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES DONE. SUSPECT IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. PATIENT WAS FINE POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 11025218 ↗
• InjuryNov 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A SYMFONY LENS DISLOCATED. IT WAS LEARNED THAT THE PATIENT HAD UNEXPECTED POST-OP OUTCOME. THE DOCTOR REPOSITIONED THE LENS AND THE SECONDARY SURGERY WENT WELL. NO PATIENT ADVERSE EVENTS, NO PATIENT POST-OP INJURIES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 10902037 ↗
• InjurySep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING BLURRED VISION IN THE LEFT EYE WITH AN INTRAOCULAR LENS (IOL). PATIENT REPORTED DISTANCE VISION IS MUCH WORSE THAN BEFORE THE SURGERY. PATIENT CAN READ BUSINESS CARDS AND LETTERS JUST FINE AS THAT GOT BETTER, HOWEVER, PATIENT FEELS LEFT EYE DOES NOT FEEL RIGHT. PATIENT ALSO REPORTED HAVING SWELLING IN THE EYE, WAS SENT TO A RETINAL SPECIALIST, THEN WAS GIVEN STEROID EYE DROPS TO TREAT THE SWELLING. THE SWELLING WENT DOWN AND GOT BETTER, BUT PATIENT SAYS EYE DOES NOT FEEL THE SAME. PATIENT COMPLAINS PERIPHERAL IS OFF, AND WHEN DRIVING VISION IS NOT AS GOOD-IT IS BLURRY/HAZY/NOT AS CRISP OF VISION. VISUAL ISSUES INTERFERE WITH DAILY ACTIVITIES. PATIENT WEARS PRESCRIPTION SUNGLASSES, SO EYE CAN ADJUST AND WEARS GLASSES FOR DISTANCE. THE SURGEON INFORMED PATIENT THE LENS IS PERFECTLY PLACED AND THERE IS NO ADHESION. NO OTHER TREATMENT HAS BEEN PROVIDED. AT THIS TIME, THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Swelling; Vitreous Floaters

  MAUDE report 10548976 ↗
• InjurySep 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT PATIENT IS POST RADIAL KERATOTOMY (RK) AND HAS A PANOPTIX TORIC IN THE OTHER EYE. THE PATIENT IS VERY UNHAPPY WITH THE SYMFONY INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT HAD BLURRED VISION AT DISTANCE UNCORRECTED. THERE WAS NO LOSS OF 2 OR MORE LINES BEST SPECTACLE CORRECTED VISUAL ACUITY(BSCVA). PRE OP VA: 20/70 SC 20/40 CC POST RK (REMOTE) AND POST OPERATIVE VISUAL ACUITY (VA): 20/60 SC 20/25-1 CC NEAR J5 SC. ADDITIONAL INFORMATION PROVIDED THAT THE LENS WAS EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10498030 ↗
• InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN A CLINICAL RESEARCH STUDY CASE, AT 1-MONTH POST-OPERATIVE VISIT, THE SUBJECT REPORTED OF BEING VERY BOTHERED BY HALOS AND STARBURSTS AND HAVING A LOT OF DIFFICULTY WITH NIGHT DRIVING. THE BEST-CORRECTED VISUAL ACUITY (BCVA) FOR BOTH EYES WERE REPORTED TO BE 20/20. IT WAS INDICATED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATION AND/OR RELATED INJURY REPORTED. ON (B)(6) 2020, THE PATIENT RETURNED FOR THE 6-MONTH POSTOP VISIT AND REPORTED OF BEING VERY BOTHERED BY HALOS AND STARBURSTS. THE PATIENT INDICATED THEY DO NOT LIKE TO DRIVE AT NIGHT WITH THE HALOS SO BRIGHT, THAT IT IS HARD TO TELL EXACTLY WHAT TRAFFIC IS COMING OR WHERE IT IS COMING FROM AND THAT THE BRIGHT RAYS MAKE IT DIFFICULT TO DRIVE SAFELY IN NIGHT TRAFFIC. THE SURGEON DETERMINED THAT THE VISUAL SYMPTOMS ARE RELATED TO REFRACTIVE ERROR AND NOT THE PRE-SURGERY ISSUES. THE LENS REMAINS IMPLANTED IN THE PATIENT'S EYE WITH NO INTERVENTION PLANNED. NO ADDITIONAL INFORMATION WAS PROVIDED. PRE-OP VISUAL ACUITY: UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA): 20/70 RIGHT EYE (OD), 20/70 LEFT EYE(OS). BEST CORRECTIVE VISUAL ACUITY (BCVA): 20/25 RIGHT EYE (OD), 20/20 LEFT EYE(OS). 6-MONTH VISUAL

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 10212299 ↗
• MalfunctionFeb 29, 2020Adverse 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 +22.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE OF PATIENT NOT HAPPY WITH VISION, PER SURGEON THERE WAS FLUCTUATION OF VISION, MODERATE POSTERIOR CHAMBER HAZE, RESIDUAL ASTIGMATISM, AND SLIGHT LAMELLAR DEFECT. PATIENT REPORTED THIS SYMPTOM TO THE SURGEON RIGHT AFTER THE SURGERY. REPORTEDLY LENS EXCHANGE WAS WITH PLACEMENT OF CAPSULAR TENSION RING AND LENS WITH MODEL ZXT150 AND LOWER DIOPTER OF 21.0 WAS USED AS REPLACEMENT FOR THE PATIENT. THERE WAS NO PATIENT INJURY, NO VITRECTOMY AND NO INCISION ENLARGEMENT REQUIRED. PATIENT WAS DOING EXCELLENT AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Corneal Edema; No Code Available; Visual Disturbances

  MAUDE report 9772473 ↗
• InjuryFeb 4, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO A MECHANICAL COMPLICATION OF THE LENS. THE INCISION WAS WIDENED AND A SUTURE WAS PLACED. THERE WERE NO OTHER COMPLICATIONS. THE REPLACEMENT LENS WAS A DIFFERENT MODEL AND HIGHER DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Macular Edema; No Code Available; Visual Impairment

  MAUDE report 9663692 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED SHE UNDERWENT BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS, MODEL ZXR00 FOR THE RIGHT EYE (OD) AND ZXT150 FOR THE LEFT EYE (OS) IN (B)(6) 2018. SINCE SURGERY THE PATIENT HAS EXPERIENCED MANY VISUAL ISSUES AND UNDERGONE SUBSEQUENT PROCEDURES TO FIX THE ISSUES. THE PATIENT REPORTS HER VISON IS BLURRY AT ALL DISTANCES WITH SIGNIFICANTLY WORSE STARBURSTS AND HALOS. SHE WAS TOLD THAT SHE HAS POSTERIOR CAPSULE WRINKLING. A YTTRIUM ALUMINUM GARNET (YAG) PROCEDURE WAS PERFORMED IN BOTH EYES ONCE, TWICE IN THE LEFT EYE. THE PATIENT CLAIMS SHE WAS LEFT WITH LARGE PIECE HANGING MID EYE AND FLOATERS. SHE REPORTS UNDERGOING A VITRECTOMY, IN BOTH EYES WITH NO COMPLICATIONS IN THE RIGHT EYE, BUT THE LEFT EYE LEAKED FOR FOUR DAYS. THE PATIENT REPORTS THAT HER VISION IS WORSE IN BOTH EYES WITH THE LENSES IMPLANTED THAN THEY WERE WITH CATARACTS. HER NIGHT VISION IS SIGNIFICANTLY WORSE, STARBURSTS AND HALOS ARE MUCH LARGER AND VERY INTENSE. SHE GETS NAUSEOUS AND DIZZY WHEN ATTEMPTING TO DRIVE AT NIGHT. SHE HAS STARBURSTS AND HALOS DURING THE DAY LIGHT WHICH SHE NEVER HAD BEFORE THE IMPLANTS. THE PATIENT¿S EYES ARE VERY SENSITIVE TO LIGHT. ONCE WHEN DRIVING INTO THE SUN AND EXPE

  Patient problems: Blurred Vision; Dry Eye(s); Headache

  MAUDE report 9645636 ↗
• InjuryJan 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED BILATERAL LENS EXPLANTS OF TECNIS SYMFONY INTRAOCULAR LENSES (IOL), MODEL ZXR00 DUE TO THE FEMALE PATIENT EXPERIENCING DISABLING HALOS AND GLARE. SYMPTOMS WERE FIRST NOTED IMMEDIATELY POST-OP FOR BOTH EYES. IT WAS INDICATED THAT THE INCISION WAS ENLARGED TO REMOVE THE IOL AND SUTURES WERE REQUIRED. A REPLACEMENT LENS, MODEL ZCB00 23.0 DIOPTER WAS USED. NO OTHER SURGICAL/MEDICAL INTERVENTIONS WERE REPORTED. THE PATIENT'S OUTCOME WAS REPORTED TO BE FAVORABLE, STABLE AFTER THE IOL EXCHANGES AND THERE WAS NO PATIENT INJURY REPORTED. IT WAS INDICATED THAT THE LENSES ARE AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED. VISUAL ACUITY PRE-OP 20/70; 20/60, VISUAL ACUITY POST-OP 20/20; 20/25. THIS MDR REPORT PERTAINS TO THE LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE (OD).

  Patient problems: Halo; No Code Available

  MAUDE report 9635388 ↗
• InjuryDec 18, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO A MECHANICAL FAILURE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9491856 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HALOS AND GLARE, THEREFORE, THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL INTERVENTION REQUIRED. A NON-JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT LENS. THE PATIENT WAS DISCHARGED AND IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Halo; No Code Available

  MAUDE report 9406652 ↗