TECNIS IOL ZXT150 (REF ZXT150U235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 05050474605275), received between Nov 17, 2016 and Jan 19, 2023 — classified as 26 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 26 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JNJ INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO THEM EXPERIENCING HALOS, GLARE AND STARBURSTS WITH NIGHT DRIVING. THE REPLACEMENT IOL IS MODEL DIU150 22.5 DIOPTER. REPORTEDLY, THE DATE OF THE FIRST SYMPTOM WAS AROUND AUGUST 30, 2022 THROUGH SEPTEMBER 27, 2022. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION SUCH AS CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT OR SUTURES. THE PATIENT IS HAPPY AS THE GLARE AND HALOS ARE MUCH IMPROVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Halo; Visual Disturbances

  MAUDE report 16210464 ↗
• InjuryNov 19, 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 LEFT EYE DUE TO THE DOCTOR "CHANGED THE LENS." THE PROBLEM WAS NOT RELATED TO USER ERROR. A NON-JOHNSON AND JOHNSON IOL WAS IMPLANTED AS A REPLACEMENT (DIOPTER 22.5). THE INCISION WAS ENLARGED AND A VITRECTOMY WAS PERFORMED. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 15830440 ↗
• InjuryOct 25, 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 LEFT EYE, DUE TO THE "DOCTOR CHOSE WRONG LENS". ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, ZXR00, DIFFERENT DIOPTER OF 25.5). THERE WAS NO MEDICAL OR SURGICAL INTERVENTION AND NO PATIENT INJURY. THE PATIENT IS DOING WELL POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 15671266 ↗
• InjuryOct 25, 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 DUE TO A SPHERICAL ERROR AND PATIENT COMPLAINED OF LARGE HALOS. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. ANOTHER JOHNSON & JOHNSON LENS, MODEL ZCT150 23.5 DIOPTER, WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Halo

  MAUDE report 15670942 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR EXPLANTED AN INTRAOCULAR LENS (IOL) FROM A PATIENT'S RIGHT EYE AND REPLACED IT WITH A NEW POWER. THERE WAS NO PATIENT INJURY REPORTED. IT WAS INDICATED THAT THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 11626140 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT ONE MONTH VISIT A CLINICAL PATIENT REPORTED BEING VERY BOTHERED BY HALOS. IT WAS ALSO STATED THAT THE PATIENT CANNOT DRIVE AT NIGHT. VISUAL ACUITY- 20/15 RIGHT EYE (OD); 20/20 LEFT EYE (OS). NO INTERVENTION PLANNED. THE PRE-OPERATIVE BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA): 20/25 OD, 20/30 OS. HOWEVER, THE SUBJECT RETURNED ON AN UNSCHEDULED VISIT. ALTHOUGH BCDVA WAS 20/20 FOR BOTH EYES (OU), YTTRIUM ALUMINUM GARNET (YAG) CAPSULOTOMY WAS PERFORMED FOR OU WHICH WAS BECAUSE OF POSTERIOR CAPSULE OPACIFICATON (PCO) OU. THE SUBJECT REPORTED BEING EXTREMELY BOTHERED BY HALOS-DRIVE AT NIGHT; VERY BOTHERED BY STARBURSTS- DRIVE AT NIGHT; EXTREMELY BOTHERED BY GLARE- COMPUTER WORK, DRIVING AT NIGHT, GLARE BOTHERS THE PATIENT OFTEN WHEN WALKING AROUND IN MY HOME BECAUSE OF LIGHT FROM WINDOWS. NO OTHER INFORMATION WAS PROVIDED. 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; Visual Disturbances

  MAUDE report 11181426 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER AND EXPLANTED DUE TO COMPLAINT OF MYOPIC ASTIGMATISM. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY. THE LENS IS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10469242 ↗
• InjuryApr 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO POOR VISION. THE REPLACEMENT IOL WAS MODEL ZCT150 23.5 DIOPTER. REPORTEDLY, THERE WAS NO INJURY TO THE PATIENT, AND THERE WERE NO COMPLICATIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. THRU FOLLOW-UP THE FOLLOWING WAS EXPLAINED. THE PATIENT WAS DIAGNOSED WITH AMETROPIA BEFORE SURGERY AND WAS HOPING THE LENS THAT WAS TO BE IMPLANTED (ZXT150) WOULD IMPROVE HER VISION. AFTER THE SURGERY THE PATIENT COMPLAINED THAT HER VISION DIDN¿T IMPROVE AND SHE STILL HAD FUNCTIONAL LIMITATIONS. THE LENS WAS EXCHANGED FOR A MODEL ZCT150. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 9961001 ↗
• InjuryDec 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF HALOS. THEREFORE, THE INTRAOCULAR LENS (IOL) WAS SCHEDULED FOR AN IOL EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Halo; No Code Available

  MAUDE report 9399212 ↗
• InjuryNov 13, 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 FROM THE LEFT EYE DUE TO INTOLERANCE AS THE PATIENT REPORTED SHE WAS VERY BOTHERED BY HALOS/RINGS. EVENT WAS A PATIENT ISSUE; THERE WAS NOTHING WRONG WITH THE LENS. THE LENS WAS REPLACED WITH A TORIC LENS. THERE WAS NO REPORTED MEDICAL INTERVENTION AT EXPLANT. THE PATIENT IS STILL ADJUSTING TO THE REPLACEMENT LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 9313813 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT¿S LEFT EYE DUE TO DYSPHOTOPSIA. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES PERFORMED. THE IOL WAS REPLACED WITH A ZCT150 AND THE PATIENT WAS FINE POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 9121099 ↗
• InjuryMar 16, 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 AND REPLACED WITH A DIFFERENT MODEL ZXT300. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY PERFORMED. REPORTEDLY, THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8427192 ↗
• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 23.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM THE LEFT EYE (OS) DUE TO PATIENT'S EXPERIENCE OF REFRACTIVE LENS INTOLERANCE, GLARE. THE REPLACEMENT LENS WAS A MODEL ZCT150 23.0 DIOPTER. THERE WAS NO VITRECTOMY OR INCISION ENLARGEMENT REQUIRED. THERE WAS NO OTHER MEDICAL OR SURGICAL INTERVENTION AND NO PATIENT INJURY REPORTED. IT WAS INDICATED THAT THE PATIENT WAS HAPPY AND THAT THE SYMPTOMS HAVE RESOLVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8356761 ↗
• InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXT150 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2018. PATIENT REPORTS FROM DAY ONE (01) VERY BLURRY DISTANCE VISION, BUT READING WAS OUTSTANDING. SHE WAS NOT ABLE TO DRIVE FOR A COUPLE OF MONTHS DUE TO BLURRED VISION AND NOT BEING ABLE TO READ STREET SIGNS, ETC. SHE NOW ONLY DRIVES IN FAMILIAR PLACES. PATIENT REPORTS GLARE IS A SERIOUS PROBLEM DAY AND NIGHT WITH HALOS AT NIGHT. HER EYES ARE ALWAYS RED EVEN WITH 6-8 TIMES USING THE SYSTANE ULTRA NON-PRESERVATIVE DROPS. THE DOCTOR PLANS TO LASER OFF THE GROWTH AROUND AND BEHIND THE LENSES NEXT AND GIVE HER PRESCRIPTION GLASSES. PATIENT ALSO REPORTS SHE WAS DIAGNOSED WITH NARROW ANGLED GLAUCOMA. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. THIS REPORT CAPTURES INFORMATION FOR IOL IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE), IOL SERIAL NUMBER (B)(4).

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 8324079 ↗
• InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXT150 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2018. PATIENT REPORTS FROM DAY ONE (01) OF VERY BLURRY DISTANCE VISION, BUT READING WAS OUTSTANDING. SHE WAS NOT ABLE TO DRIVE FOR A COUPLE OF MONTHS DUE TO BLURRED VISION AND NOT BEING ABLE TO READ STREET SIGNS, ETC. SHE NOW ONLY DRIVES IN FAMILIAR PLACES. PATIENT REPORTS GLARE IS A SERIOUS PROBLEM DAY AND NIGHT WITH HALOS AT NIGHT. HER EYES ARE ALWAYS RED EVEN WITH 6-8 TIMES USING THE SYSTANE ULTRA NON-PRESERVATIVE DROPS. THE DOCTOR PLANS TO LASER OFF THE GROWTH AROUND AND BEHIND THE LENSES NEXT AND GIVE HER PRESCRIPTION GLASSES. PATIENT ALSO REPORTS SHE WAS DIAGNOSED WITH NARROW ANGLED GLAUCOMA. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. THIS REPORT CAPTURES INFORMATION FOR IOL IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE), IOL SERIAL NUMBER (B)(4).

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 8324040 ↗
• InjuryOct 28, 2018Break; Break

  IT WAS REPORTED THAT A ZXT150 23.5 DIOPTER LENS WAS IMPLANTED AND DID NOT CENTER CORRECTLY AND THERE WAS AN ATTEMPT TO REPOSITION THE LENS. REPORTEDLY, THE HAPTIC WAS DAMAGED DURING THE ORIGINAL FOLDING, WHICH CAUSED THE PATIENT'S CAPSULAR BAG TO RUPTURE. THE DAMAGED HAPTIC DETACHED AND BECAME STUCK/ADHERED TO THE CAPSULAR BAG COULDN'T BE REMOVED. THE LENS HAD TO BE CUT OUT LATER. THIS EVENT MAY BE DUE TO A USE ERROR DURING HANDLING/PREPARATION OF THE LENS FOR IMPLANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 8011494 ↗
• InjuryOct 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 23.5 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 BECAUSE THE PATIENT WAS COMPLAINING OF VISUAL DISTURBANCE AND SEEING RINGS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A ZCT150 23.5 DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8008436 ↗
• InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 23.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO A -4.00 REFRACTIVE SURPRISE. AT EXPLANT THERE WAS AN INCISION ENLARGEMENT AND SUTURES REQUIRED, BUT NO VITRECTOMY WAS PERFORMED. THE LENS WAS REMOVED WITHOUT COMPLICATIONS AND REPLACED WITH A ZXR00 19.5 DIOPTER LENS. THE PATIENT IS VERY PLEASED WITH THE RESULTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7986173 ↗
• InjuryOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, DUE TO AN UNSPECIFIED MECHANICAL COMPLICATION. THE REPLACEMENT LENS WAS A NON JOHNSON AND JOHNSON LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7982178 ↗
• InjuryAug 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS. LEFT EYE (OS): LENS MODEL ZXR00 +17.5 DIOPTER IMPLANTED ON (B)(6) 2018, RIGHT EYE (OD): LENS MODEL ZXT150 +23.5 DIOPTER IMPLANTED ON (B)(6) 2018. REPORTEDLY, THE PATIENT COMPLAINED OF SEEING HALOS AND STARBURST DURING THE DAY AND NIGHT; EXPERIENCED DECREASED DISTANCE VISION AND A SHADOWING EFFECT OVER THE ENTIRE FIELD OF VISION, ESPECIALLY NOTICEABLE WHEN READING CAPTIONS. DRIVING AND WATCHING TV WERE GREATLY AFFECTED. THE PATIENT DEVELOPED AN INFLAMMATION IN (B)(6) WHICH THE DOCTOR SAID CAN HAPPEN AFTER CATARACT SURGERY AND WAS PRESCRIBED DUREZOL. THE PATIENT HAS ALSO DEVELOPED A SECONDARY CATARACT BUT THERE ARE NO PLANS TO DEAL IT UNTIL THE INFLAMMATION HAS BEEN RESOLVED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO RECORD THE LENS IMPLANTED IN THE LEFT EYE (OS). A SEPARATE MDR WILL BE FIELD FOR THE LENS IN THE RIGHT EYE (OD).

  Patient problems: Halo; Inflammation; Visual Impairment

  MAUDE report 7760721 ↗
• InjuryJun 19, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE TECNIS SYMFONY TORIC INTRAOCULAR LENS (MODEL ZXT150 +23.5 DIOPTER) WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, AS THE DOCTOR REALIZED THAT THE DIOPTER WAS INCORRECT FOR THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT LENS WAS EXPLANTED ALSO BECAUSE THE PATIENT'S VISION REMAINED BLURRY AFTER THE INITIAL SURGERY AND WAS EXPERIENCING WORSE NEAR VISION THAN PRE-OP. REPORTEDLY, LENS MODEL ZXT150 +25.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED BEING STABLE WHEN DISCHARGE WITH NO COMPLICATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7612879 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED FROM A FEMALE PATIENT WHO HAD A ZXT150 23.5 INTRAOCULAR LENS (IOL) IMPLANTED INTO HER RIGHT EYE (OD) ON (B)(6) 2017. THE PATIENT REPORTED SOME ISSUES TO THE SURGEON ABOUT 1-2 WEEKS POST IMPLANTATION. IT WAS NOTED THAT HER DISTANT VISION WAS FINE WITH 20/20, BUT SHE FELT LIKE SHE WAS LOOKING THROUGH A "SARAN WRAP". THE PATIENT USED GLASSES FOR NEAR VISION. SHE WAS COMPLAINING OF SEEING SPIKES FROM LIGHT SOURCES. THERE WAS ALSO A GHOSTING ISSUE, WHILE READING. HOWEVER, THE PATIENT COULD READ WITHOUT ANY ISSUES WHEN SHE USED HER GLASSES. REPORTEDLY, THE PATIENT SAW NO IMPROVEMENT REGARDING HER VISUAL ISSUES DURING THE TIME THE LENS WAS IMPLANTED. MOREOVER, THE SYMPTOMS MADE DRIVING DIFFICULT. THE LENS WAS EXPLANTED AND A NEW LENS IMPLANTED (MODEL AND DIOPTER UNKNOWN) BY A SECOND SURGEON. THE PATIENT COMMENTED THAT THE EXPLANTING SURGEON WOULD NOT HAVE SELECTED A MULTIFOCAL LENS INITIALLY, BASED ON THE PATIENT'S PREVIOUS HISTORY WITH LASIK SURGERY IN OD. WITH THE REPLACEMENT LENS, THE PATIENT'S SYMPTOMS DISAPPEARED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE INCISION WAS NOT ENLARGED TO REMOVE THE LENS AND THERE WERE NO INJURIES DURING THE EXPL

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7569733 ↗
• InjuryMay 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS (MODEL ZXT150, +23.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE IN A SECONDARY PROCEDURE BECAUSE SURGEON MISSED TARGET. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE EXPLANT TOOK PLACE DUE TO +0.4 HYPEROPIC MISS AND PATIENT EXPERIENCING BLURRY VISION. A MODEL ZXT150, +25.5 DIOPTER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. CUSTOMER CONFIRMED THERE WAS NO INCISION ENLARGEMENT, NO PATIENT INJURY AND NO MEDICAL INTERVENTION. PATIENT WAS REPORTED AS BEING STABLE AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7531054 ↗
• InjuryMay 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON EXPLANTED TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (ZXT150, +23.5 DIOPTER) FROM PATIENT¿S OPERATIVE EYE. REPORTEDLY LENS FROM ANOTHER MANUFACTURER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7528038 ↗
• InjuryFeb 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT COMPLAINT OF HALO. THE LENS WAS REPLACED WITH A MONOFOCAL NON-AMO LENS. IT WAS REPORTED THAT THE PATIENT IS DOING WELL. THERE WAS NO INCISION ENLARGEMENT REQUIRED AND NO VITRECTOMY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7249982 ↗