TECNIS IOL ZXT150 (REF ZXT150U210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 05050474605220), received between Nov 11, 2016 and May 1, 2023 — classified as 33 injuries.

The most frequently reported specific device problem is “Inaccurate Delivery” (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 33 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2023Adverse 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 RIGHT EYE, WHICH WAS FIRST IDENTIFIED DURING A POST-OPERATIVE EXAM. THE LENS WAS EXPLANTED BECAUSE THE SURGEON ORIGINALLY PUT IN A TORIC LENS AND THE TORIC POWER WAS TOO STRONG (IT OVER CORRECTED THE ASTIGMATISM), WHICH WAS BOTHERING THE PATIENT, SO THE SURGEON EXCHANGED THE TORIC LENS FOR A NON-TORIC LENS. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, ZXR00, SAME DIOPTER). THERE WAS NO PATIENT INJURY. NO SUTURE OR VITRECTOMY WAS REQUIRED. THERE WAS NO DELAY IN PROCEDURE. THE END-USER DID NOT SEEK MEDICAL ATTENTION. THE PATIENT IS FULLY RECOVERED AND IS DOING SATISFACTORY POST-SURGERY. DIRECTIONS FOR USE WERE FOLLOWED. THE PRODUCT IS NOT AVAILABLE TO BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16850701 ↗
• InjuryJun 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 AS THE PATIENT REFRACTED A BIT MYOPIC, COULD NOT READ WELL AND THE DISTANCE WAS BLURRED. WHEN THE DOCTOR CORRECTED THAT THE PATIENT REPORTED THAT HER NEAR WAS EVEN WORSE AND THE PATIENT HAD EARLY POSTERIOR CAPSULE OPACIFICATION (PCO). THE PATIENT WAS NOT UNHAPPY WITH THE SYMPHONY TORIC LENS. THE ORIGINAL LENS IMPLANTED WAS SELECTED USING IOL MASTER 700, ALCON ORA GUIDANCE AND FLAC. FOR THE EXPLANT PROCEDURE, THE SAME INCISIONS ACCESSED AND NO VITRECTOMY, NO SUTURES AND NO COMPLICATIONS WERE REPORTED. A REPLACEMENT LENS OF DIFFERENT MODEL AND DIOPTER (20.5D) WAS USED. IT WAS INDICATED THAT THERE WAS NO YTTRIUM-ALUMINUM GARNET (YAG) CAPSULOTOMY PERFORMED, BUT IT WILL BE REQUIRED TO ACHIEVE BEST VISION LATER. REPORTEDLY, THE PATIENT'S OTHER EYE IS EMMETROPIC WITH AN IMMATURE CATARACT AND DRY EYE WHICH IS NOT READY FOR SURGERY. PATIENT'S SYMPTOMS ON THE LEFT EYE: ON (B)(6) 2021, POOR NEAR VISION. ON (B)(6) 2021, POOR FAR SC 20/40, NEAR J7. ON (B)(6) 2021, WORSE FAR SC 20/60, REFRACTION MYOPIC -1.00+0.75@95 BUT CC NEAR POOR, FAR NOT SUBJECTIVELY ACCEPTABLE WITH REFRACTION, EARLY PCO2+. OCT NL MACU

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Dry Eye(s); Visual Impairment

  MAUDE report 11987459 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT INDICATING THE PATIENT WAS EXPERIENCING GLARE AND HALOS ESPECIALLY AT NIGHT. THE PATIENT WAS NO LONGER ABLE TO DRIVE AT NIGHT DUE TO THE GLARE. THE INTRAOCULAR LENS (IOL) WAS EXPLANTED, THE INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11986330 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE BECAUSE THE PATIENT COMPLAINED OF HAVING BLURRY VISION ONE WEEK AFTER THE IMPLANT. THE PATIENT ALSO REPORTED CLOUDINESS, SHADOWS, AND DOUBLE VISION. BSCVA (BEST SPECTACLE CORRECTED VISUAL ACUITY) WAS 20/40 + 2 BEFORE AND AFTER WAS 20/20. THE CUSTOMER NOTED THAT THE PATIENT SEEMS HAPPY AT ONE-DAY POST-OPERATION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 11408625 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL STUDY SUBJECT WAS IMPLANTED BILATERAL INTRAOCULAR LENSES (IOLS) AND COMPLETED THE PATIENT-REPORTED VISUAL SYMPTOM QUESTIONNAIRE AT THE 1 MONTH VISIT AND REPORTED EXTREMELY BOTHERED BY HALOS, NIGHT DRIVING IS DIFFICULT; EXTREMELY BOTHERED BY SCATTERED LIGHT, DRIVING; VERY BOTHERED BY POOR LOW LIGHT VISION, READING IN LOW LIGHT. VISUAL ACUITY- 20/25 RIGHT EYE (OD); 20/20 LEFT EYE (OS). SUBJECT REPORTS SYMPTOMS AS DEBILITATING. HOWEVER, NO INTERVENTION PLANNED AT THIS TIME. PRE-OPERATIVE BCDVA: 20/30 RIGHT EYE, 20/20 LEFT EYE IT WAS LEARNED THAT THE SUBJECT RETURNED FOR A 6-MONTH VISIT. MONOCULAR UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA): 20/40 OD, 20/20 OS; BCDVA: 20/30 OD, 20/20 OS. THE PATIENT REPORTED VISUAL SYMPTOM COMPLAINTS FOR BOTH EYES (OU) ON THE QUESTIONNAIRE: SUBJECT REPORTED BEING EXTREMELY BOTHERED BY HALOS, WORRY A LOT WHEN DRIVING AT NIGHT THAT THE HALOS COVER UP A CAR AHEAD OF ME WHEN ANOTHER CAR IS APPROACHING; EXTREMELY BOTHERED BY STARBURSTS- THE PATIENT FEELS THAT IT IS MORE DIFFICULTY TO DRIVE AT NIGHT THAN BEFORE, HOWEVER CAN STILL DRIVE; EXTREMELY BOTHERED BY SENSITIVITY TO LIGHT- THE PATIENT SQUINTS WITHOUT SUNGLASSES; AND EXTR

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11387245 ↗
• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 INTRAOCULAR LENS WAS EXPLANTED. THE PATIENT REFRACTED -0.62 -1.25 X160. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT MODEL, ZXR00 20.0 DIOPTER LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Visual Impairment

  MAUDE report 11320100 ↗
• InjuryOct 9, 2020Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT A ZXT150 MODEL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE THE LENS WAS IMPLANTED UPSIDE DOWN. DOCTOR HAD NOTICED THAT LENS FLIPPED UPSIDE DOWN WHILE INSERTING LENS INTO THE EYE AND IT WAS NOTICED DURING POST OP THAT PATIENT VISION WAS NEGATIVELY IMPACTED. THERE WAS NO PATIENT INJURY AND NO MEDICAL/SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE REQUIRED. THE REPLACEMENT LENS USED IS A SAME MODEL AND DIOPTER LENS. THE PATIENT WAS DOING FINE AT THE TIME OF DISCHARGE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE NO VISUAL SYMPTOMS EXPERIENCED BY THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 10659373 ↗
• 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 STILL UNHAPPY WITH THE VISUAL OUTCOME WITH THE REPLACEMENT LENS, THEREFORE, EXPLANTED AND REPLACED WITH ANOTHER LENS WITH A DIFFERENT SURGEON AT ANOTHER FACILITY. NO FURTHER INFORMATION WAS AVAILABLE. PATIENT HAD THE ORIGINAL LENS AND REPLACEMENT LENS EXPLANTED. THIS REPORT CAPTURES THE REPLACEMENT LENS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ORIGINAL LENS.

  Patient problems: No Code Available

  MAUDE report 10309127 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT''S RIGHT (OD) OPERATIVE EYE ON (B)(6) 2017. AT 1 DAY POSTOP, PATIENT COMPLAINT OF BLURRY VISION AND AT 9TH DAY HALOS WAS REPORTED. PATIENT'S PRE AND POST-OP BEST-CORRECTED VISUAL ACUITY (BCVA): PRE: 20/40; POST: 20/25+. THE FACILITY WAS INFORMED THAT THE PATIENT HAD A LENS EXCHANGE PERFORMED BY A DIFFERENT SURGEON DUE TO INABILITY TO ADJUST. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAS BILATERAL IMPLANTS. THIS REPORT REPRESENTS THE RIGHT (OD) EYE AND A SEPARATE REPORT IS SUBMITTED FOR THE LEFT (OS) EYE.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 9242321 ↗
• InjurySep 6, 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 EXPLANTED DUE TO THE PATIENT EXPERIENCING BLURRY VISION IN THE RIGHT EYE. THE EXPLANTED IOL WAS REPLACED WITH A ZCB00 IOL. THERE WAS NO REPORT OF INCISION ENLARGEMENT, VITRECTOMY OR SUTURES THAT WERE PERFORMED. THE PATIENT WAS WELL POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8968376 ↗
• InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING HALOS AND COULD NOT ADJUST AFTER THE IMPLANTATION OF LENS MODEL, ZXT150 MULTIFOCAL IOL (INTRAOCULAR LENS). AS A RESULT, LENS WAS EXPLANTED. IT WAS NOTED THAT EXCHANGE WENT FINE AND NO SUTURES NEEDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8493428 ↗
• InjuryMar 22, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF LENS MODEL, ZXT150 MULTIFOCAL IOL (INTRAOCULAR LENS) THERE WAS A UNSPECIFIED MECHANICAL COMPLICATION. THE LENS WAS EXPLANTED AND REPLACED WITH A +21.0 DIOPTER ZCT150 LENS. NO COMPLICATION WAS REPORTED AFTER REPLACEMENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8446508 ↗
• InjuryMar 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IIT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPEROPIA AFTER THE IMPLANTATION OF THE TORIC ZXT150 MULTIFOCAL IOL (INTRAOCULAR LENS) +21.0 DIOPTER. AS A RESULT, THE LENS WAS EXPLANTED AND REPLACED WITH +21.5 DIOPTER LENS MODEL, ZLBOO MULTIFOCAL IOL. IT WAS ALSO NOTED THAT THE INCISION WAS NOT ENLARGED, NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8443299 ↗
• InjuryJan 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2019 FOR UNKNOWN REASONS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A ZA9003 20.0 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8279783 ↗
• InjuryJan 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 INTRAOCULAR LENS WAS IMPLANTED ON (B)(6) 2018 AND EXPLANTED ON (B)(6) 2018 DUE TO PATIENT COMPLAINT OF BLURRY DISTANT VISION REPORTED DURING A POST-OPERATIVE EXAMINATION. ADDITIONAL INFORMATION RECEIVED REVEALED THE ISSUE WAS FIRST REPORTED/DIAGNOSED ON (B)(6) 2018. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL INTERVENTION PERFORMED. A REPLACEMENT LENS OF THE SAME MODEL WAS IMPLANTED INTO THE OPERATIVE (OS) EYE. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8264543 ↗
• InjuryDec 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150, 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO REFRACTIVE ERROR/GLARE. THERE WERE NO COMPLICATIONS, NO SUTURE, AND NO INCISION ENLARGEMENT PERFORMED. IT WAS LEARNT THAT THE LENS WAS EXCHANGED FOR A ZCT150 22.5 DIOPTER. MOREOVER, VISUAL ACUITY WAS 20/30- WITH 0.75 -0.75 @ 90 DEGREES. CURRENT VISUAL ACUITY IS 20/25, AND VISUAL SYMPTOMS ARE MAINLY RESOLVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8205380 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXT150 21.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE OF PATIENT EXPERIENCING GLARE. A MODEL ZCB00 22.5 DIOPTER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, NO VITRECTOMY REQUIRED. PATIENT IS DOING WELL POST EXCHANGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8204675 ↗
• InjuryDec 7, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE ZXT150 +21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE POST-OP REFRACTION WAS DIFFERENT FROM THE ONE PREDICTED DUE TO CORNEAL ABNORMALITIES. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO PATIENT INJURY WAS REPORTED. A ZXT150 +22.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. REPORTEDLY, THE OUTCOME IS EXCELLENT AND THE PATIENT IS HAPPY; THE NEW POST-OP REFRACTION IS NEAR PLANO. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8140659 ↗
• InjuryNov 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 +21.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 FOR UNKNOWN REASONS. THE REPLACEMENT LENS WAS A ZA9003 +21.0 DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8031970 ↗
• InjurySep 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 21.0 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 RESIDUAL OF MYOPIA OUTCOME. THE REPLACEMENT LENS WAS A ZXR00 20.0 DIOPTER LENS. THERE WAS NO INCISION ENLARGEMENT, AND ONLY SUTURES WERE USED. REPORTEDLY, THE PATIENT IS DOING GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7858023 ↗
• InjuryAug 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A BILATERAL INTRAOCULAR LENS (IOL) IMPLANT. RIGHT EYE: ZXT150 +21.0 DIOPTER IMPLANTED ON (B)(6) 2018. LEFT EYE: ZXT150 +21.0 DIOPTER IMPLANTED ON (B)(6) 2018. REPORTEDLY, THE PATIENT IS UNHAPPY. SHE CANNOT DRIVE AT NIGHT AS IT IS TOO DANGEROUS. SHE CAN SEE GIANT SUNBURSTS SURROUNDING HALOS AROUND LIGHTS, SHADOWS ON THE SIDE OF THE RIGHT EYE. THE LEFT EYE HAS WAVES ON LEFT SIDE LIKE ''HEAT WAVES''. THE EYES ALWAYS FEEL IRRITATED AND RAW. THE PATIENT COMMENTED THAT HER SIDE VISION IS IMPAIRED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE SURGEON ADVISED THE PATIENT TO GIVE HER EYES TIME TO ADAPT. HER EYES ARE STILL IRRITATED AND SHE HAS NOT SOUGHT TREATMENT FOR THIS ISSUE YET. THE PATIENT ALSO MENTIONED THAT SHE DOES NOT WANT TO HAVE ANY ADDITIONAL PROCEDURES PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. THIS MDR IS TO RECORD THE LENS IMPLANTED IN THE LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Halo; Irritation; Visual Disturbances

  MAUDE report 7823129 ↗
• InjuryAug 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A BILATERAL INTRAOCULAR LENS (IOL) IMPLANT. RIGHT EYE: ZXT150 +21.0 DIOPTER IMPLANTED ON (B)(6) 2018; LEFT EYE: ZXT150 +21.0 DIOPTER IMPLANTED ON (B)(6) 2018. REPORTEDLY, THE PATIENT IS UNHAPPY. SHE CANNOT DRIVE AT NIGHT AS IT IS TOO DANGEROUS. SHE CAN SEE GIANT SUNBURSTS SURROUNDING HALOS AROUND LIGHTS, SHADOWS ON THE SIDE OF THE RIGHT EYE. THE LEFT EYE HAS WAVES ON LEFT SIDE LIKE ''HEAT WAVES''. THE EYES ALWAYS FEEL IRRITATED AND RAW. THE PATIENT COMMENTED THAT HER SIDE VISION IS IMPAIRED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE SURGEON ADVISED THE PATIENT TO GIVE HER EYES TIME TO ADAPT. HER EYES ARE STILL IRRITATED AND SHE HAS NOT SOUGHT TREATMENT FOR THIS ISSUE YET. THE PATIENT ALSO MENTIONED THAT SHE DOES NOT WANT TO HAVE ANY ADDITIONAL PROCEDURES PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. THIS MDR IS TO RECORD THE LENS IMPLANTED IN THE RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

  Patient problems: Halo; Irritation; Visual Disturbances

  MAUDE report 7823109 ↗
• InjuryJul 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SYMFONY ZXT150 +21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE ON (B)(6) 2018. IMMEDIATELY AFTER SURGERY THE PATIENT WAS REPORTED TO BE UNHAPPY AND COMPLAINED OF BLURRED VISION, HALOS AND GLARE. THE LENS WAS EXPLANTED ON (B)(6) 2018 AND REPLACED WITH A ZCT150 +21.0 DIOPTER. THE INCISION WAS ENLARGED TO REMOVE THE LENS. NO VITRECTOMY WAS PERFORMED AND NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS SEEN ONE DAY POST-OP AND WAS REPORTED TO BE WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 7701765 ↗
• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 21.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT EXPERIENCED ISSUES WITH GLARE. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY PERFORMED, BUT SUTURING WAS REQUIRED. ALSO, DUE TO ZONULAR DEHISCENCE, A MORCHER CAPSULAR TENSION RING (CTR) WAS USED. THE REPLACEMENT LENS WAS A TORIC LENS FROM A DIFFERENT MANUFACTURER. REPORTEDLY, THERE WAS PATIENT INJURY AND WHEN ASKED IF THE PATIENT IS DOING FINE POST-OPERATIVELY THE RESPONSE WAS NO. HOWEVER, NO SPECIFICS WERE PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Zonular Dehiscence

  MAUDE report 7535952 ↗
• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 21.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. HOWEVER, THERE ARE PLANS TO EXPLANT THE LENS BECAUSE THE PATIENT EXPERIENCED ISSUES WITH GLARE. THE PLANNED REPLACEMENT LENS WILL BE A TORIC LENS FROM ANOTHER MANUFACTURER. THERE IS NO SET DATE FOR THE PLANNED EXPLANT YET, AS THEY ARE WAITING FOR THE PATIENT TO HEAL FROM THE FIRST PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7535951 ↗