TECNIS IOL ZXT150 (REF ZXT150U220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 05050474605244), received between Apr 7, 2017 and May 25, 2021 — classified as 30 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO HAD BILATERAL IMPLANTS REPORTED OF EXPERIENCING ISSUES WITH BOTH EYES. THE PATIENT HAS PROBLEMS WITH STARBURST, HALOS AS WELL AS LIGHTS DURING DAY AND NIGHT, BUT SHE IS MOSTLY TROUBLED BY THE STARBURST WHICH HAS AFFECTED HER NIGHT DRIVING. THE PATIENT REPORTED THAT SHE CAN NO LONGER DRIVE AT NIGHT AS SHE IS REALLY BOTHERED/BLINDED BY THE LIGHTS AND THAT HER NIGHT VISION IS BASICALLY GONE. IT WAS INDICATED THAT THE SYMPTOMS STARTED RIGHT AFTER THE CATARACT SURGERIES. DURING THE DAY THE PATIENT IS FINE AND PERFORMS HER DAILY TASKS BUT SOMETIMES EVEN DURING THE DAY SHE IS BOTHERED BY THE LIGHTS SUCH AS LIGHT REFLECTIONS FROM CHROME COLOR CARS. THE PATIENT CONSULTED WITH HER PHYSICIAN AND HAS BEEN GIVEN MEDICATION (ALPHAGAN P) TO USE FOR TWO MONTHS. THE RETINA SPECIALIST THE PATIENT WAS REFERRED TO IN (B)(6) 2021, DID NOT THINK THERE WERE ISSUES WITH HER RETINA AND ALSO PRESCRIBED HER WITH A MEDICATION CALLED PROLENSA. THE PATIENT WAS USING REFRESH TEARS FOR HER DRY EYE WHICH WAS TOLD IT IS NOT STRONG ENOUGH. THE PATIENT¿S DOCTOR TOLD HER THAT SHE MAY GET USED TO THE LENSES WITHIN TIME, BUT SHE HAS NOT AFTER ALL THIS TIME. THE PATIENT DISCUSSED THE OPTION OF EXCHAN

  Patient problems: Dry Eye(s); Flashers; Halo; Visual Disturbances

  MAUDE report 11874596 ↗
• InjuryFeb 11, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO MECHANICAL ISSUE. THERE WAS VITRECTOMY AND INCISION ENLARGEMENT. THIS WAS REPLACED WITH A DIFFERENT MODEL IOL. THERE WAS NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11312388 ↗
• InjuryFeb 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNCOMPLICATED CATARACT EXTRACTION WITH A TECNIS SYMFONY INTRAOCULAR LENS (IOL). THE LENS WAS SUBSEQUENTLY EXPLANTED/EXCHANGED FIVE WEEKS POST-IMPLANT DUE TO MYOPIC SHIFT, BLURRED VISION AT DISTANCE. MANIFEST REFRACTION POST-OPERATIVELY = -1 SPHERE. PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) 20/40. POST-OP BCVA 20/20. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 11299309 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A FEMALE PATIENT STATUS POST (S/P) LASIK, IMPLANTED WITH A SYMFONY INTRAOCULAR LENS (IOL), IN THE SECOND EYE (LEFT EYE (OS), POST-OP DAY ONE (POD 1), VISUAL ACUITY (VA) WAS 20/30 AND J1. THEN POST-OP WEEK ONE (POW 1) THE PATIENT¿S VA DROPPED TO 20/125. AFTER TREATING FOR DRY EYES, SHE IS NOW AT 20/70 WITH J1. HER DISTANCE HAS DECREASED BUT HER CPU AND NEAR ARE GREAT. SHE HAS HALOS THAT ARE GETTING BETTER. ALSO NOTED THAT HER SURFACE WAS MUCH BETTER, BUT DISTANCE VISION AND STARBURSTS CONTINUE TO BE A PROBLEM. HER FIRST EYE IS DOING GREAT S/P LASIK IN THE PAST WITH SYMFONY PLACEMENT. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS PROVIDED FOR THE LEFT EYE. PRE-OP DATA +2.00 +0.75 X 178 DISTANCE 20/30, NEAR J1, MILD DRY EYES, RETINA EXAM AND OPTICAL COHERENCE TOMOGRAPHY (OCT) MACULA WERE STABLE. POST-IMPLANT DATA: POD 1 DISTANCE SANS CORRECTION (SC) 20/30, NEAR SC J1 POST-OP WEEK ONE (POW 1) DISTANCE SC 20/125. PIN HOLE (PH) TO 20/30, NEAR SC J2. PT WAS DILATED AND NO CYSTOID MACULAR EDEMA (CME) NOTED BUT SURFACE APPEARED MORE IRRITATED - DISCUSSED TEARS POST-OP MONTH ONE (POM 1) DISTANCE SC 20/100, PH TO 20/40, NEAR SC J1. MANIFEST REFRACTION (MRX) OS +1

  Patient problems: Dry Eye(s); Halo; Visual Disturbances

  MAUDE report 11085474 ↗
• 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 (LEFT EYE) AND EXPLANTED DUE TO COMPLAINT OF POST HYPEROPIA. IOL WAS REPLACED WITH THE SAME MODEL LENS WITH A DIFFERENT DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS: STABLE AND NO VISUAL ISSUES, 20/30 UNCORRECTED. THE LENS IS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10469314 ↗
• InjuryJul 22, 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 AS THE PATIENT WAS VERY UNHAPPY WITH THE VISUAL EXPERIENCE. FURTHER INFORMATION WAS PROVIDED AND IT WAS LEARNED THAT THE PATIENT WAS NOT HAPPY WITH THE VISION OUTCOME OR HER EXTENDED RANGE VISION. PATIENT COMPLAINED OF VISION NOT BEING SHARP, VISION WAS FUZZY, PATIENT SAW STARBURSTS AND GHOSTING IMAGES, AND DID NOT LIKE TO DRIVE AT NIGHT. THERE WAS NO VITRECTOMY OR SUTURES REQUIRED WHEN REMOVING THE LENS. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND LOWER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS FINE POST-OPERATIVELY WITH NO COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT HAD THE ORIGINAL LENS AND REPLACEMENT LENS EXPLANTED. THIS REPORT CAPTURES THE ORIGINAL LENS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE REPLACEMENT LENS.

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

  MAUDE report 10309101 ↗
• 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 10212279 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BEGAN SEEING HALOS WHEN SHE DRIVES AT NIGHT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN HER RIGHT EYE LAST YEAR. THE PATIENT WAS IMPLANTED WITH AN IOL IN THE LEFT EYE PRIOR TO THE IMPLANT IN THE RIGHT EYE. THE PATIENT SEES PERFECTLY AND IS VERY HAPPY WITH HER VISION, EXCEPT FOR NIGHT DRIVING. THE PATIENT STATED THE HALOS ARE SO BIG SHE CANNOT SEE THE ROAD. THE HALOS ONLY APPEAR WITH CAR HEADLIGHTS. THE PATIENT CAN DRIVE ON THE FREEWAY; HOWEVER, SHE CANNOT DRIVE ON REGULAR STREETS. THE PATIENT HAS TRIED TO USE YELLOW LENS GLASSES AND SUNGLASSES, BUT NEITHER HAVE HELPED WITH THE HALOS. THROUGH FOLLOW-UP, THE PATIENT REAFFIRMED SHE SEES HALOS WHILE DRIVING ON CITY STREETS AND WHILE LOOKING AT RED LIGHTS. THE PATIENT NOTICED THE HALOS ABOUT A MONTH AFTER SHE HAD HER SECOND EYE (RIGHT EYE) DONE ON (B)(6) 2019. THE PATIENT INDICATED THAT SHE DID NOT DRIVE FOR A WHILE AND ONLY NOTICED THE HALOS WHEN SHE STARTED DRIVING AT NIGHT. THE PATIENT HAD HER 1-YEAR VISIT AND THE SURGEON STATED EVERYTHING LOOKED FINE AND HER EYE PRESSURE IS GREAT. NO OTHER INFORMATION WAS PROVIDED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN

  Patient problems: Halo

  MAUDE report 9936387 ↗
• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT150 +22.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE OF PATIENT EXPERIENCING MYOPIA. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. NO PATIENT INJURY REPORTED. REPORTEDLY THE REPLACEMENT LENS WAS THE SAME MODEL, BUT LOWER DIOPTER (+21.5). THE PATIENT IS DOING WELL POST-EXCHANGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9804138 ↗
• 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 9645643 ↗
• InjuryJan 7, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) IMPLANTED INTO THE PATIENTS LEFT EYE WAS SLIGHTLY OFF-CENTER AND THAT THERE WAS A CAPSULE TEAR. THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 9560037 ↗
• InjuryNov 20, 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 IMPLANTED IN A PATIENT BUT THE PATIENT DEVELOPED HAZY/BLURRY VISION. IT WAS LEARNED THAT AN EXPLANT IS PLANNED, BUT THIS WILL NOT TAKE PLACE UNTIL SPRING/SUMMER OF 2020 PER THE PATIENT¿S REQUEST. THE PATIENT IS HOPING FOR IMPROVEMENT TO AVOID EXPLANTATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9351296 ↗
• InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE 6-MONTH STUDY VISIT, THE SUBJECT IMPLANTED WITH A ZXT150 INTRAOCULAR LENS (IOL), REPORTED HALOS, STARBURSTS, SENSITIVITY TO LIGHT AND POOR LIGHT VISION WHICH SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE IOL REMAIN IMPLANTED IN THE SUBJECT AND THERE IS NO PLANNED TREATMENT. THERE ARE NO OTHER PATIENT COMPLICATIONS AND/OR RELATED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS MDR CAPTURES THE EVENT FOR THE LEFT EYE; A SEPARATE MDR WILL BE SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 9151122 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS INCLUDED IN A CLINICAL STUDY OF (B)(6). THE PATIENT WAS IMPLANTED A BILATERAL ZXT150 INTRAOCULAR LENS (IOL). IT WAS LEARNT THAT AT ABOUT THE 6TH MONTH OF FOLLOW-UP, THE SUBJECT NOTED: VERY BOTHERED BY HALOS: DIFFICULT TO SEE CLEARLY WHEN HEADLIGHTS ARE FACING TOWARD ME / ALSO HAVE HALOS IN MY HOME AROUND LIGHT SOURCES LIKE CLOCK RADIO LIGHT. VERY BOTHERED BY STARBURSTS: SEEING CLEARLY WHEN HEADLIGHTS ARE COMING AT ME AT NIGHT. VERY BOTHERED BY GLARE RELATED TO SCATTERED LIGHT: VERY BOTHERED ON A TWO LANE ROAD. MODERATELY BOTHERED BY POOR LOW LIGHT VISION: READING MENUS OR SMALL PRINT THE SYMPTOMS DO INTERFERE WITH DAILY ACTIVITIES. THE IOLS STILL REMAIN IMPLANTED IN THE SUBJECT IN BOTH EYES WITH NO INTERVENTION PLANNED. PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (BCVA): RIGHT EYE (OD) 20/40, LEFT EYE (OS) 20/50 6 MONTH BCVA OD 20/20 OS 20/20. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE RIGHT EYE (OD). A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE (OS).

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8975178 ↗
• InjuryJun 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC INTRAOCULAR LENS (MODEL ZXT150 +22.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF THE PATIENT BEING UNHAPPY AND EXPERIENCING GLARE. A MODEL ZCT150 +22.0 DIOPTER LENS WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT INCISION WAS ENLARGED DURING THE PROCEDURE AND THE EXPLANTED LENS WAS DISCARDED. PATIENT WAS DOING FINE AT DISCHARGE. VISUAL ACUITY PREOP 20/20. 1ST PROCEDURE VISUALS ACUITY PREOP 20/20. 2ND PROCEDURE (EXCHANGE)VISUAL ACUITY PREOP 20/30 ONE DAY POST OP. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8677512 ↗
• InjuryMay 17, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AT THE 1-DAY POST OP VISIT, THE INTRAOCULAR LENS (IOL) IMPLANTED INTO THE LEFT EYE WAS OBSERVED TO HAVE ROTATED FROM ITS INITIAL POSITION OF 08 DEGREES TO A POSITION OF 173 DEGREES. THE PATIENT COMPLAINED OF BLURRY VISION. THE IOL WAS ROTATED AT SLIT LAMP AT THE 1 DAY POST-OP VISIT. THERE WAS NO PATIENT INJURY AND THE ISSUE DOES NOT SIGNIFICANTLY AFFECT THE PATIENT¿S ABILITY TO COMPLETE ACTIVITIES OF DAILY LIFE. THE PATIENTS VISUAL ACUITY HAS IMPROVED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8618599 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXT150 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2018 AND REPLACED WITH A ZCT150 22.0 DIOPTER IOL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8534476 ↗
• InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SYMFONY TORIC INTRAOCULAR LENS (MODEL ZXT150 22.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S OPERATIVE EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF A SLIGHT HYPEROPIC OUTCOME AND PATIENT BEING UNHAPPY ABOUT NEAR VISION. REPORTEDLY, THE LENS ZLB00 22.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO VITRECTOMY, NO SUTURES, AND NO INCISION ENLARGEMENT REQUIRED. PATIENT¿S OUTCOME AND VISION WAS REPORTED TO BE EXCELLENT AFTER THE EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8296116 ↗
• InjuryJan 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD POOR NEAR AND DISTANT VISION AFTER THE IMPLANTATION OF MODEL ZXT150 TECNIS MULTIFOCAL IOL (INTRAOCULAR LENS). AS A RESULT, THE IOL HAD TO BE EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. THE ACCOUNT COMMENTED THAT THE EXPLANTED LENS WAS DESTROYED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8207778 ↗
• InjuryDec 5, 2018Mechanical Problem; Positioning Problem; Mechanical Problem; Positioning Problem

  IT WAS REPORTED THAT A ZXT150 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018, AND LATER EXPLANTED ON (B)(6) 2018 DUE TO MULTIPLE ADVERSE SYMPTOMS. PATIENT'S VISUAL ACUITY PRE-OPERATIVE WAS 20/30. PATIENT EXPERIENCED HALOS AND GLARE (DYSPHOTOPSIA), BLURRY VISION, AND MYOPIA AFTER THE PROCEDURE. THE CUSTOMER ALSO INDICATED MECHANICAL COMPLICATION AND POSITIONING ISSUE WITH THE LENS. PATIENT'S VISUAL ACUITY POST-OPERATIVE IS 20/60. THE EXPLANTED LENS WAS REPLACED WITH ANOTHER ZXT150 OF A LOWER DIOPTER (20.5). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 8136163 ↗
• InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 22.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT COMPLAINED THAT THE VISION WAS JUST NOT GOOD FOR DISTANCE AND NEAR, INCLUDING EXCESSIVE GLARE WITH METALLIC ITEMS. THE REPLACEMENT LENS WAS A ZA9003 20.5 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8132113 ↗
• MalfunctionDec 4, 2018Break; Break

  IT WAS REPORTED THAT A ZXT150 22.0 DIOPTER LENS WAS RECEIVED CRUMBLED AND UNABLE TO BE USED. IT WAS ALSO CONFIRMED THAT THIS EVENT DID NOT OCCUR DURING HANDLING AND PRIOR TO INSERTION, BUT WHEN THE PACKAGE (LENS BOX) WAS RECEIVED AND OPENED. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8131632 ↗
• InjuryOct 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POOR DISTANCE VISION AFTER IMPLANTATION OF A MODEL ZXT150 TECNIS MULTIFOCAL IOL (INTRAOCULAR LENS) IN HER RIGHT EYE (OD). AS A RESULT, THE SURGEON PLANS TO EXPLANT THE IOL AND REPLACE IT WITH ANOTHER ZXT150 MODEL LENS OF A DIFFERENT DIOPTER POWER. VISUAL ACUITY PRE-OP 20/50; VISUAL ACUITY POST-OP 20/70. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8011215 ↗
• InjuryOct 24, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT150 22.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT HAD A MYOPIC SHIFT OF -1.00 WHEN THE GOAL WAS PLANO. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. VISUAL ACUITY PRE-OPERATIVELY WAS 20/50 WITH 2400 GLARE VISION AND THE VISUAL ACUITY POST-OPERATIVELY WAS 20/50. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 20.5. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. THE DEVICE WAS ACCIDENTLY DISCARDED BY THE SURGERY CENTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8003157 ↗
• MalfunctionJun 25, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE SURGERY CENTER REPORTED THAT WHEN THEY OPENED THE ZXT150 22.0 DIOPTER INTRAOCULAR LENS (IOL) CONTAINER AND FLIPPED THE DOOR, A VERY SMALL PIECE OF PLASTIC WAS OBSERVED BY THE TECHNICIAN ON THE LENS. IT LOOKED LIKE THE PLASTIC WAS A PART OF SOMETHING THAT SHOULD NOT BE ON THE LENS. THEREFORE, THE CENTER DID NOT USE THE LENS AND IT NEVER MADE IT TO THE CARTRIDGE. THEY USED THE BACK-UP LENS INSTEAD AND THE SURGERY WENT WELL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7635964 ↗