TECNIS IOL ZXT150 (REF ZXT150U225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 05050474605251), received between Dec 12, 2016 and Sep 24, 2021 — classified as 31 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Torn Material” (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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REMOVED THE TECNIS SYMFONY INTRAOCULAR LENS (IOL) FROM THE PATIENT'S RIGHT (OD) EYE AND REPLACED WITH AN EYHANCE TORIC IOL OF THE SAME DIOPTER. THE EXPLANT OCCURRED DUE TO PATIENT FIRST COMPLAINED OF HAVING HEADACHES ON (B)(6) 2021 AND LATER COMPLAINED OF DISTANCE VISION NOT SHARP ENOUGH. THE PATIENT STATED THAT HE DID NOT LIKE THE HALOS AND THE LOW LIGHT CONDITIONS MADE HIM NOT FEEL SAFE WHEN DRIVING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Headache; Visual Disturbances

  MAUDE report 12530587 ↗
• 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 EXCHANG

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

  MAUDE report 11874619 ↗
• InjuryFeb 11, 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 A PATIENT¿S LEFT EYE DUE TO SYMPTOMS OF GLARE AT NIGHT AND STARBURST WHICH WERE DISABLING TO THE PATIENT. THE SYMPTOMS STARTED ABOUT 1-WEEK POST-OP. THE PATIENT WAITED ONE-MONTH POST OPERATION TRYING TO ADAPT AND SEE IF THE GLARE/STARBURSTS IMPROVED TO TOLERABLE LEVEL. THE PATIENT IS HAPPY WITH THE DISTANCE AND NEAR VISON, BUT THE NIGHT GLARE/STARBURSTS WERE DISABLING; THEREFORE, THE PATIENT ELECTED TO HAVE AN IOL EXCHANGE. THE PATIENT IS HAPPY WITH THE DISTANCE ONLY ON THE OTHER EYE WITH MONOFOCAL TORIC LENS. IT WAS NOTED THAT THE ISSUES WERE OBSERVED DURING POST-OP EXAMINATION. THERE WAS NO VITRECTOMY PERFORMED, AND NO INCISION ENLARGEMENT OR SUTURES REQUIRED. NO DELAY IN THE PROCEDURE WAS REPORTED. THE PATIENT HAS A PRIOR HISTORY OF RADIAL KERATOTOMY (R.K.) SURGERY IN1990'S. NO FURTHER INFORMATION WAS PROVIDED. VISUAL ACUITY PRE-OP: 20/30. VISUAL ACUITY POST-OP: 20/25 DISTANCE/J3 NEAR.

  Patient problems: Flashers; Visual Disturbances

  MAUDE report 11319971 ↗
• InjuryJul 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED FROM A PATIENT'S LEFT EYE (OS) IN A SECONDARY SURGICAL PROCEDURE. THE LENS WAS EXPLANTED ON (B)(6) 2020. THERE WAS NO FURTHER INTERVENTION REPORTED AND THE PATIENT OUTCOME WAS GOOD. IT WAS INDICATED THAT THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 10330825 ↗
• InjuryJul 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 A PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE. THE PATIENT HAD SEVERE BLURRING AS WELL AS GLARE AND WAS UNABLE TO SEE CLEARLY WITH THE LENS. REPORTEDLY, THE INCISION WAS ENLARGED AND A SUTURE WAS REQUIRED. A REPLACEMENT LENS, MODEL ZCB00 +23.0 DIOPTER WAS USED. IT WAS INDICATED THAT THE PATIENT IS DOING WELL AT 1-DAY POST OPERATION AND NO PATIENT INJURY WAS REPORTED. IT WAS NOTED THAT THE LENS WAS DISCARDED AND WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10291827 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE CATARACT WAS REMOVED AND THE LENS WAS FULLY INSERTED IN A PATIENT¿S LEFT EYE, THE DOCTOR NOTICED VITREOUS. A VITRECTOMY HAD TO BE PERFORMED AND THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. A REPLACEMENT LENS, MODEL ZMA00 (22.0 DIOPTER) WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 10126969 ↗
• 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 RIGHT EYE; A SEPARATE MDR WILL BE SUBMITTED FOR THE LEFT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 9151088 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS IMPLANTED IN BOTH EYES. REPORTEDLY PATIENT¿S VISION IS LITTLE OUT OF FOCUS WITH NO DISCOMFORT. PATIENT UNDERSTOOD THAT THERE WAS NO GUARANTEE OF THE CLOSE-UP VISION, HOWEVER 2FT-8FT THINGS ARE CLEAR- PAST 15-20 FT THINGS ARE OUT OF FOCUS. SURGEON RULED OUT LASIK AND OFFERED TO REPLACE THE LENS. PATIENT HAS BEEN USING BOLE SUNGLASSES THAT HAS A YELLOWISH TINT AND WHEN PATIENT WEARS THEM THE VISION GETS CLEARER- THEY ARE STOCK- NONPRESCRIPTION LENSES. THIS REPORT WILL CAPTURE INFORMATION FOR PATIENT¿S LEFT EYE. ANOTHER REPORT IS BEING SUBMITTED FOR PATIENT¿S RIGHT OPERATIVE EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8997364 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS IMPLANTED IN BOTH EYES. REPORTEDLY PATIENT¿S VISION IS LITTLE OUT OF FOCUS WITH NO DISCOMFORT. PATIENT UNDERSTOOD THAT THERE WAS NO GUARANTEE OF THE CLOSE-UP VISION, HOWEVER 2FT-8FT THINGS ARE CLEAR- PAST 15-20 FT THINGS ARE OUT OF FOCUS. SURGEON RULED OUT LASIK AND OFFERED TO REPLACE THE LENS. PATIENT HAS BEEN USING BOLE SUNGLASSES THAT HAS A YELLOWISH TINT AND WHEN PATIENT WEARS THEM THE VISION GETS CLEARER- THEY ARE STOCK- NONPRESCRIPTION LENSES. THIS REPORT WILL CAPTURE INFORMATION FOR PATIENT¿S RIGHT EYE. ANOTHER REPORT IS BEING SUBMITTED FOR PATIENT¿S LEFT OPERATIVE EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8997158 ↗
• InjuryAug 7, 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 DUE TO PATIENT DEVELOPING DYSPHOTOPSIA. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. THE PATIENT RECOVERED POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8869233 ↗
• InjuryAug 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXT150 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENTS RIGHT EYE DUE TO COMPLAINT OF BLURRY VISION DURING A POST-OP VISIT. THE EXPLANTED IOL WAS REPLACED WITH ANOTHER IOL OF THE SAME MODEL BUT DIFFERENT DIOPTER. THERE WAS NO ADDITIONAL INTERVENTION NOR INJURY TO THE PATIENTS EYE. THE EXPLANTED IOL WAS NOT SAVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8853254 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 TORIC SYMFONY INTRAOCULAR LENS (IOL) IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO AN INCORRECT LENS POWER FOR THE PATIENT. THERE WAS NO INCISION ENLARGEMENT OR SUTURE REQUIRED AND THE PATIENT IS REPORTEDLY DOING GOOD POST-SURGERY WITH THE REPLACEMENT LENS, A MODEL ZXR00 SYMFONY, 22.5 DIOPTER. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8809790 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS COMPLAINING OF STARBURSTS, RINGS AROUND LIGHT, GHOSTS IN HER EYE, WEDGES- AS IF THE LENS WAS TOO SMALL, AS WELL AS A BLUR. SHE NEVER WORE READING GLASSES, NOW SHE NEEDS THEM. HER EYES ARE WORSE NOW THAN PRIOR TO SURGERY, SHE WAS PROMISED SHE WOULD GET 20/30 IN HER RIGHT EYE. SHE WAS ABLE TO READ PRESCRIPTION BOTTLES AND NOW SHE CAN'T. IT¿S BEEN 3 YEARS SINCE HER SURGERY, SHE HAS BEEN THROUGH MULTIPLE EYE TESTS. SHE IS NOT VERY HAPPY. FOLLOW-UP WITH THE IMPLANTING DOCTOR WAS CONDUCTED. THE PATIENT¿S PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/50 RIGHT EYE (OD) AND 20/25- LEFT EYE (OS) WITH GLARE. HER POST OP BCVA WAS 20/25 BOTH EYE (OU). THE DOCTOR STATED THAT DESPITE EXPLAINING ALL OF THE RISKS (INCLUDING THE GLARE AND HALOES THAT THE PATIENT IS EXPERIENCING) AND BENEFITS OF MULTIFOCAL LENS IMPLANTS PREOPERATIVELY, THE PATIENT STATES THAT THEY WERE NEVER EXPLAINED TO HER. THE DOCTOR OFFERED HER IOL EXCHANGE, BUT SHE HAS REFUSED. THE DOCTOR ALSO OFFERED HER A SECOND OPINION, WHICH SHE HAS REFUSED. 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: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 8572035 ↗
• InjuryApr 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150, 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE (OD) AS THE PATIENT WAS NOT ABLE TO TOLERATE THE REFRACTIVE QUALITY OF THE LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES DONE AT EXPLANT. NO PATIENT POST-OP INJURY. THE LENS WAS REPLACED WITH A NON J&J LENS. THE PATIENT WAS REPORTED AS DOING FINE. IT WAS LEARNT THAT THE VISUAL SYMPTOMS SIGNIFICANTLY INTERFERED WITH THE PATIENT¿S REGULAR ACTIVITIES. NO OTHER INFORMATION WAS PROVIDED. VISUAL ACUITY: PRE-OP BCVA (BEST CORRECTED VISUAL ACUITY): 20/25 +2 J7; POST-OP BCVA: 20/20.

  Patient problems: No Code Available

  MAUDE report 8533823 ↗
• InjuryApr 4, 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 DUE TO DYSPHOTOPSIA. THE LENS WAS REPLACED WITH A MODEL ZCT150 22.5 DIOPTER LENS. THE PATIENT WAS REPORTED DOING WELL POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8485302 ↗
• InjuryFeb 20, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT150 22.5 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE ON (B)(6) 2018. THE IOL WAS NOTICED TO HAVE ROTATED ON (B)(6) 2018 AND WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2019. FOLLOWING THE EXCHANGE, THE PATIENT IS HAPPY WITH IMPROVED VISION. ADDITIONAL INFORMATION RECEIVED REVEALED THE IOL WAS IMPLANTED AT 30 DEGREES AND PRESENTED TO THE EXPLANTING SURGEON AT 180 DEGREES. THE REPLACEMENT LENS WAS OF THE SOME MODEL AND SIMILAR DIOPTER. THERE WERE NO PATIENT INJURIES AND NO OTHER MEDICAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8356490 ↗
• InjuryFeb 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT HAD BILATERAL INTRAOCULAR LENS (IOL) IMPLANT IN (B)(6) 2018. REPORTEDLY, THE PATIENT EXPERIENCED HALOS, BLURRED VISION AND LINES IN THE HALO. THE RIGHT EYE (OD) IS WORSE THAN THE LEFT (OS). HE STATED THAT HIS DOCTOR DID NOT RECOMMEND AN EXPLANT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PATIENT DEVELOPED VISUAL ISSUES RIGHT AWAY POST-OP. THE PATIENT HAS DIFFICULTY DRIVING AT NIGHT DUE TO HALOS. CAN SEE CLOSE-UP BETTER THAN CAN SEE INTERMEDIATE AND FAR DISTANCE. DOCTOR GIVES HIM EYE DROPS (LOTEMAX 4X/DAY, XIIDRA 2X/DAY, SYSTANE 6-8X/DAY) TO ADDRESS HIS VISUAL ISSUES. NO OTHER INFORMATION WAS PROVIDED. THIS MEDICAL DEVICE REPORT (MDR) PERTAINS TO THE LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE (OD).

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 8347031 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 22.5 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 DUE TO POOR READING VISION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 23.5. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. THE ACCOUNT COMMENTED THAT THE EXPLANTED LENS IS NOT AVAILABLE FOR INSPECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8234929 ↗
• InjuryDec 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 22.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO ANISOMETROPIA. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 20.0. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8166935 ↗
• InjuryOct 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 22.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON AN (B)(6) 2018. IT WAS LATER EXPLANTED ON AN UNKNOWN DATE BECAUSE THE PATIENT'S VISION FLUCTUATES, IS BLURRY, AND RINGS ARE BEING SEEN AROUND LIGHTS. REPORTEDLY, THE PATIENT PRESENTED WITH BINOCULAR 20/30 DISTANCE VISION AND NEAR J6. THE PATIENT HAD 1.00 ASTIGMATISM PRE-OP AND WAS REPORTED SAME, 1.00 POST OPERATIVELY. THERE WAS AN INCISION ENLARGEMENT PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 8016453 ↗
• InjuryOct 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD UNEXPECTED POST-OP REFRACTION AFTER IMPLANT OF A ZXT150 MULTIFOCAL IOLS (INTRAOCULAR LENS). AS A RESULT, THE PATIENT WAS NOT HAPPY WITH HIS RESULTS. THE DOCTOR BELIEVED THAT IOL HAD FLIPPED HIS ASTIGMATISM CAUSING THE PATIENT TO HAVE RESIDUAL ASTIGMATISM. THE LENS WAS EXPLANTED AND REPLACED WITH A ZCT300 21.5 LENS. AN INCISION ENLARGEMENT ALONG WITH A SUTURE WERE USED DURING LENS REPLACEMENT. THERE WAS NO PATIENT POST-OP INJURY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7932625 ↗
• InjuryMar 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 22.5 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 BECAUSE THE PATIENT WANTED A DIFFERENT POWERED LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A ZXT225 22.0 DIOPTER LENS. REPORTEDLY, THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7380550 ↗
• InjuryFeb 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018, DUE TO THE PATIENT COMPLAINING OF SEVERE STARBURSTS, HALOS AND GLARE THAT INTERFERED WITH NIGHT TIME VISION. THERE WAS NO INCISION ENLARGEMENT PERFORMED, NO SUTURES USED, AND NO COMPLICATIONS. THE LENS WAS REPLACED WITH A NON AMO LENS AND THE PATIENT WAS REPORTED DOING GOOD POST OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7284319 ↗
• InjuryFeb 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE LEFT EYE (OS) OF THE PATIENT ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018, DUE TO HALOS AND GLARE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THE LENS WAS REPLACED WITH ZCBOO 22.5 DIOPTER IOL. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING GOOD POST-OPERATIVELY.NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7246328 ↗
• InjuryJan 30, 2018Invalid Sensing; Invalid Sensing

  IT WAS REPORTED THAT A ZXT150 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE RIGHT EYE (OD) OF THE PATIENT ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT CAN NOT SEE NEAR AND OR COMPUTER VISION, AND THE PATIENT FEELS THAT THEIR VISION IS WORSE THAN BEFORE SURGERY. TO DATE, LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7229774 ↗