TECNIS IOL ZXT150 (REF ZXT150U185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 05050474605176), received between Jan 2, 2018 and Mar 13, 2023 — classified as 23 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD CATARACT SURGERY IN THE LEFT EYE. POST OPERATIVELY THERE WAS A REFRACTIVE SURPRISE AND THE LENS WAS EXPLANTED. THE PLAN WAS TO IMPLANT A JOHNSON & JOHNSON LENS (DIFFERENT MODEL, ZXR00, DIFFERENT DIOPTER OF 28.5). AN UNPLANNED VITRECTOMY WAS REQUIRED AND A THREE PIECE LENS WAS IMPLANTED INSTEAD OF THE PLANNED ZXR00.

  Patient problems: Visual Impairment

  MAUDE report 16535070 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL SUBJECT RETURNED FOR 6 MONTH VISIT. UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) 20/25 RIGHT EYE (OD), 20/20 LEFT EYE (OS); BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) 20/20 BOTH EYES (OU). ON THE QUESTIONNAIRE, THE SUBJECT NOTED AS VERY BOTHERED BY STARBURSTS WHILE DRIVING AT NIGHT. NO PLANS FOR SURGICAL INTERVENTION AT THIS TIME. FOLLOW-UP CONFIRMED THAT THE SUBJECT STATED THE STARBURSTS IN PARTICULAR ARE DEBILITATING. HE DESCRIBED THEM AS SEVERE AND STATED THAT HE IS UNABLE TO DRIVE AT NIGHT DUE TO THE STARBURSTS. THE DOCTOR DISCUSSED LENS EXCHANGE AND YTTRIUM ALUMINUM GARNET (YAG) WITH PATIENT TO TRY TO RELIEVE THESE SYMPTOMS. PATIENT IS SCHEDULED FOR A YAG EVALUATION ON (B)(6) 2021 TO DETERMINE IF THIS IS THE OPTION HE WILL PROCEED WITH. UNSCHEDULED VISIT NOTED UCDVA 20/25 OU; BCDVA 20/15 OD, 20/20 OS. ON THE QUESTIONNAIRE, THE SUBJECT COMPLAINED BEING VERY BOTHERED BY HALOS WHILE DRIVING AT NIGHT; VERY BOTHERED BY STARBURSTS WHILE DRIVING AT NIGHT AND VERY BOTHERED BY GLARE WHILE DRIVING AND WATCHING TV. NO PLANS FOR INTERVENTION AT THIS TIME. MONTH 1 VISIT NOTED VISUAL ACUITY UCDVA 20/20 OU AND BCDVA 20/15 OU. THE FOLLOWING COMPLAINT WAS REPOR

  Patient problems: Flashers; Halo

  MAUDE report 12586604 ↗
• InjuryMay 25, 2021Adverse 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 REFRACTIVE SURPRISE. VISION PRE-OPERATIVE (OP): 20/60 AND VISION POST-OPERATIVE (OP): 20/40. THE PATIENT HAD RESIDUAL REFRACTIVE ERROR POST LENS IMPLANTATION CAUSING BLURRY VISION. AT EXPLANT, THERE WAS AN INCISION ENLARGEMENT, HOWEVER, SUTURES OR A VITRECTOMY WERE NOT REQUIRED. ANOTHER JOHNSON & JOHNSON LENS, DIFFERENT MODEL AND LOWER DIOPTER (ZXT300 18.0), WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. THE EXPLANTED LENS WAS INADVERTENTLY DISCARDED. THE PATIENT HAD NO COMPLAINTS AT TIME OF DISCHARGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 11882318 ↗
• InjuryMar 2, 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 PATIENT'S EYE AND ANOTHER LENS OPTION WAS REPLACED. SUSPECT PRODUCT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Eye Injury

  MAUDE report 11398483 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE PATIENT WANTED BETTER VISION AND WAS NOT SATISFIED WITH VISION. THERE WAS NO PATIENT INJURY AND NO MEDICAL/SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT PATIENT NOTICED DISTANCE VISION BLURRY, WANTED IMPROVED DISTANCE VISION WHILE MAINTAINING AS MUCH NEAR VISION AS POSSIBLE. SYMPTOMS SIGNIFICANTLY AFFECTED PATIENT¿S ABILITY TO PERFORM DAILY ACTIVITIES AND PATIENT WAS UNABLE TO SEE WITHOUT A CONTACT LENS FOR DISTANCE AND THE NEED FOR READING GLASSES. THE REPLACEMENT LENS USED IS A NON J&J LENS. THE PATIENT WAS DOING OKAY AT THE TIME OF DISCHARGE. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 10969332 ↗
• InjuryOct 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S OPERATIVE EYE DUE TO COMPLAINTS OF A SIGNIFICANT DIOPTER CHANGE POST-OP. ANOTHER LENS WITH THE SAME MODEL AND DIFFERENT DIOPTER SIZE WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10632144 ↗
• InjuryAug 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT¿S LEFT EYE IN SECONDARY SURGICAL PROCEDURE. THE PATIENT WAS EXPERIENCING SEVERE GLARE AT DISTANCE AND NEAR AND HALOS AT NIGHT AND WHILE WATCHING TV OR ANYTHING WITH BRIGHT LIGHTS. THE PATIENT ALSO HAD SEVERE DISTANCE AND NEAR VISON BLURRING. A REPLACEMENT LENS OF DIFFERENT MODEL/DIOPTER WAS USED. THERE WAS ONE SUTURE USED. NO PATIENT INJURY WAS REPORTED. PATIENT'S OUTCOME WAS REPORTED TO BE NORMAL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 10376095 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CLINICAL STUDY PATIENT UNDERWENT BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS. AT 1 MONTH VISIT HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS VERY BOTHERED BY HALOS, VERY DISTRACTIVE IN BUILDINGS; EXTREMELY BOTHERED BY STARBURSTS, HAD SAFETY CONCERNS WITH DRIVING; EXTREMELY BOTHERED BY MULTIPLE OR DOUBLE VISION, TOTALLY DISABLING WHEN IT OCCURS; VERY BOTHERED BY GLARE, DRIVING; MODERATELY BOTHERED BY POOR LOW LIGHT VISION, NUISANCE. PREOPERATIVE VISUAL ACUITY: BEST CORRECTED DISTANCE VISUAL ACUITY (BCVA), RIGHT EYE (OD) 20/20; LEFT EYE (OS) 20/20 THE MONOCULAR UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) ¿ OD 20/25; OS 20/25. MONOCULAR BCDVA ¿ OD 20/15; OS 20/15. ON OCULAR EXAM POSTERIOR CAPSULE OPACIFICATION (PCO)- BOTH EYES, WAS NOTED. THE SUBJECT IS SCHEDULED TO HAVE A YTTRIUM ALUMINUM GARNET (YAG) CAPSULOTOMY FOR THE POSTERIOR CAPSULE OPACIFICATION (PCO- LASER TREATMENT) IN 1 WEEK FOR THE OD AND 3 WEEKS FOR THE OS. IT WAS LEARNT THAT THE SUBJECT HAD YAG OF OD ON (B)(6) 2020. THEN ON (B)(6) 2020 ANOTHER YAG FOR THE OS. THE PATIENT VISUAL ACUITY IS UNKNOWN AT THIS TIME. NO OTHER INTERVENTION IS PLANNED. NO FURTHER INFORMATION AVAILABLE. THIS MDR REPORT PERTAINS TO

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9881588 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXT150 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO THE PATIENT EXPERIENCING VISUAL DISTURBANCE. THROUGH FOLLOW-UP, IT WAS LEARNED THE PATIENT WAS SEEING HALOS. THERE WAS NO VITRECTOMY OR SUTURES REQUIRED. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A ZCT150 22.5 (HIGHER DIOPTER). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9879541 ↗
• MalfunctionJan 30, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS. THE EVENT WAS RELATED TO LENS DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9648562 ↗
• InjuryJan 13, 2020Adverse 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 IMPLANTED IN THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. IT WAS EXPLANTED ON (B)(6) 2019 BECAUSE OF RESIDUAL MYOPIA. THERE WAS NO PATIENT INJURY. NO SURGICAL INTERVENTIONS SUCH AS: VITRECTOMY; INCISION ENLARGEMENT; OR SUTURES WERE REQUIRED. THE REPLACEMENT LENS IS A ZXT150 19.0 DIOPTER LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9583836 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD BILATERAL INTRAOCULAR LENS IMPLANTS IN HER EYES ABOUT 5 WEEKS AGO. FOLLOW-UP CONFIRMED THAT THE LENSES ARE A ZXT150, LEFT EYE (OS) AND A ZXR00, RIGHT EYE (OD). PATIENT STATED THAT HER VISION DIDN'T CHANGE EVEN AFTER >1 MONTH IMPLANT. SHE NEEDS READERS TO BE ABLE TO GO ABOUT HER DAILY ACTIVITIES. FURTHER INFORMATION WAS RECEIVED WHERE IT WAS REPORTED THAT AFTER ABOUT 4 MONTHS POST-OP, THE INTRAOCULAR LENS (IOL) IN THE PATIENT¿S RIGHT EYE WAS EXPLANTED. IOL EXPLANT WAS DUE TO PATIENT BEING UNHAPPY WITH THE QUALITY OF THE LENS. SECONDARY TO PATIENT NOT BEING ABLE TO SEE DISTANCE, SHE ALSO SAW FIREWORKS WHEN LOOKING AT STREET SIGNS, AND HAD DIPLOPIA AS WELL. THE EVENT FOR THE RIGHT EYE WAS REPORTED UNDER MDR 9614546-2019-01077. LATER FOLLOW-UP CONFIRMED THAT THE LEFT IOL WAS ALSO EXPLANTED AND REPLACED WITH MODEL ZCT150, 18.5 DIOPTER IOL. GLARE AND HALOS HAVE IMPROVED AFTER THE OD AND OS LENSES WERE REMOVED AND REPLACED. THE EXPLANTED LENS IS NOT RETURNING AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9539520 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT (OS) OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO BLURRY VISION NOT IN FOCUS AND HAVING STARBURST. PATIENT'S VISUAL ACUITY PRE-OP WAS 20/30 AND POST-OP IS 20/20-1. THE REPLACEMENT LENS IS A ZCB00 18.0 DIOPTER LENS. REPORTEDLY, THERE WAS NO SURGICAL INTERVENTION SUCH AS: INCISION ENLARGEMENT; VITRECTOMY; OR SUTURE USED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 9345069 ↗
• InjurySep 9, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT HAD DECREASED VISION, GLARE, HAD SPIDER WEB IN VISION AND A SLIGHTLY DECENTERED INTRAOCULAR LENS (IOL) LENS. A VITRECTOMY AND A LIMBAL RELAXING INCISION (LRI) WERE REQUIRED. THERE WERE NO OTHER PATIENT INJURY. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances; Vitrectomy

  MAUDE report 8976095 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem; Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED BEING MODERATELY BOTHERED BY HALOS AND STARBURSTS IN THE 4-MONTH STUDY VISIT. THE PATIENT INDICATED THAT DRIVING AT NIGHT HAS SIGNIFICANTLY INTERFERED WITH DAILY ACTIVITIES. VISUAL ACUITY WAS 20/25 IN BOTH EYES AND AT THE 4-MONTH STUDY VISIT THE PATIENT'S BEST CORRECTED DISTANCE VISION WAS 20/20 IN BOTH EYES. REPORTEDLY, THERE WAS NO PATIENT INJURY. THE PATIENT HAS A DRY EYE SYNDROME CALLED MEIBOMIAN GLAND DYSFUNCTION (MGD) AND HAD A LIPIFLOW TREATMENT AT THE END OF THE 3-MONTH VISIT. AT THIS TIME, THE LENS REMAINS IMPLANTED. THE PATIENT HAS COMPLETED THE STUDY ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. 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: Halo; No Code Available; Visual Disturbances

  MAUDE report 8658649 ↗
• InjuryApr 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) MODEL, ZXT150 18.5 DIOPTER WAS EXPLANTED FROM THE RIGHT EYE (OD) OF A PATIENT. THE REASON FOR THE EXPLANT WAS NOT PROVIDED. THE REPLACEMENT LENS WAS A ZCB00 18.5 DIOPTER MONOFOCAL LENS. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT IS FOR THE PATIENT'S RIGHT EYE (OD). A SEPARATE REPORT WILL BE FILED FOR THE PATIENT'S LEFT EYE (OS).

  Patient problems: No Code Available

  MAUDE report 8534301 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS MODEL, ZXT150 MULTIFOCAL IOL (INTRAOCULAR LENS) WAS EXPLANTED. REASON OF EXPLANT AND PATIENT INVOLVEMENT ARE UNKNOWN, NOT PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8423385 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 18.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO BLURRY VISION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE ACCOUNT COMMENTED THAT THE DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8234975 ↗
• InjuryJan 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, DUE TO THE PATIENT EXPERIENCING VISUAL DISTURBANCES. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME DIOPTER, BUT DIFFERENT MODEL ZXR00. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8229635 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXT150 + 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN PATIENT'S RIGHT EYE ON (B)(6) 2017 AND EXPLANTED ON (B)(6) 2018 DUE TO THE PATIENT COMPLAINING OF BLURRY VISION. THERE WAS NO INCISION ENLARGEMENT AND NO PATIENT INJURY. A NON JOHNSON & JOHNSON LENS (+18.0 DIOPTER SIZE) WAS IMPLANTED AS A REPLACEMENT. REPORTEDLY, POST-EXCHANGE THE PATIENT VISION HAS IMPROVED. THE ACCOUNT COMMENTED THAT THE EXPLANTED LENS WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7973653 ↗
• InjuryAug 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 18.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. POST-OPERATIVELY ON (B)(6) 2018, THE PATIENT COMPLAINED OF CLOUDY/HAZY VISION IN THE LEFT EYE. ALSO, HIS VISUAL ACUITY 20/20 (DISTANCE CORRECTED) AND J6 (NEAR DISTANCE) AND THE AUTO REFRACTION WAS -1.00 X +0.75 X 149. THE PATIENT ALSO COMPLAINED OF HALOS AND HEADLIGHTS LOOKING LIKE STARBURSTS IN REGARDS TO DISTANCE VISION WHEN DRIVING. POST-OPERATIVELY ON (B)(6) 2018, THE PATIENT COMPLAINED OF UP CLOSE BLURRY VISION. THEIR VISUAL ACUITY WAS 20/20 IN THE LEFT EYE, THE PRESCRIPTION GIVEN WAS +2.50, AND THE AUTO REFRACTION WAS -0.25 X +0.50 X 156. IT WAS LATER EXPLANTED ON (B)(6) 2018 AND REPLACED WITH A ZXT225 21.5 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 7828503 ↗
• InjuryJul 3, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT150 +18.5 DIOPTER) WAS EXPLANTED IN SECONDARY PROCEDURE FROM PATIENT¿S RIGHT EYE BECAUSE PATIENT WAS EXPERIENCING A HYPEROPTIC MISS AND SURGEON WANTED TO CHANGE TO DIFFERENT SIZE. REPORTEDLY, A MODEL ZXT150 +20.5 DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. THERE WAS NO PATIENT INJURY, NO OTHER SURGICAL OR MEDICAL INTERVENTION AND NO INCISION ENLARGEMENT. PATIENT WAS STABLE AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7659273 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS DISSATISFIED WITH THE ZXT150 INTRAOCULAR LENS (IOL) IMPLANTED IN THE RIGHT EYE (OD), THE LENS WAS EXPLANTED. THE LENS WAS REPLACED WITH A MODEL ZCT225. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7535948 ↗
• InjuryJan 2, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT150 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE WRONG POWER WAS USED. FURTHER INFORMATION PROVIDED INDICATED AN UNEXPECTED POST-OP REFRACTION POST IMPLANT AND THAT THE PATIENT WAS NOT HAPPY WITH THEIR VISION. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER OF 16.5. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7159397 ↗