TECNIS IOL ZXT225 (REF ZXT225U190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05050474605770), received between Feb 2, 2017 and Oct 20, 2023 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTING THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S LEFT EYE SHE EXPERIENCED SEVERAL SYMPTOMS. THE PATIENT CLARIFIED THAT SHE HAS A JNJ IOL IMPLANTED IN BOTH EYES. HER RIGHT EYE IS ¿PERFECT¿. IT HEALED IN TWO DAYS AND HER VISION IS 20/15. THE SAME SURGEON DID HER LEFT EYE. HOWEVER, SHE DESCRIBED HER LEFT EYE AS A ¿NIGHTMARE¿. THE LENS DIDN¿T FEEL RIGHT IN HER EYE AND IT FEELS OFF CENTER AND SHOULD BE SLID OVER MORE TOWARD HER NOSE. THE PATIENT REPORTED HAVING SYMPTOMS FROM THE BEGINNING. RIGHT AFTER THE IMPLANT HER SYMPTOMS WERE ¿DYSPHOTOPSIA¿, BLURRY VISION, GLARE, AND HALOS. WHEN SHE DRIVES, SHE SEES SPIDERWEBS AROUND THE STOP LIGHTS. FOR A WHILE SHE SAW BLACK SHADOWS. INITIALLY, SHE HAD EYE DISCHARGE BUT THAT HAS RESOLVED. ALTHOUGH THE PAIN HAS BEEN THERE FROM THE START IN (B)(6) THE PAIN SEEMED TO WORSEN WITH ADDED PRESSURE IN HER EYE. SHE FEELS IMMENSE PAIN IN HER LEFT EYE. THE PAIN STARTED THE SAME DAY OF SURGERY. SHE FEELS PAIN, PRESSURE, AND ¿FULLNESS¿ IN HER FACE. THE PATIENT REPORTED HER INTRAOCULAR PRESSURE IS BETWEEN 16-19. HOWEVER, SHE¿S INSISTING THAT SHE¿S FEELING EYE PRESSURE AND STATED THAT IT¿S BEEN HAPPENI

  Patient problems: Blurred Vision; Eye Pain; Halo; Pain; Unspecified Tissue Injury; Uveitis; Visual Disturbances

  MAUDE report 17981267 ↗
• InjuryApr 7, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXT225 INTRAOCULAR LENS WOULD NOT STAY IN PROPER POSITION IN THE PATIENTS EYE AND IT HAS BEEN EXPLANTED. LENS WAS DISCARDED. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances

  MAUDE report 16702652 ↗
• InjuryMar 18, 2023Adverse 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. THE REASON FOR THE EXPLANT WAS NOT SPECIFIED. NO MEDICAL OR OTHER SURGICAL INTERVENTIONS WERE INDICATED. IT WAS INDICATED THE PRODUCT WILL NOT BE RETURNED AS IT WAS DISCARDED. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 16569971 ↗
• InjuryJan 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL STUDY PATIENT CAME IN AGAIN WITH THIS NEW COMPLAINT THIS TIME FOR BOTH EYES, WHEN THE PATIENT CAME IN FOR THE 1ST MONTH VISIT. THE PATIENT HAD A BEST CORRECTED VISUAL ACUITY (BCVA): 20/25 BOTH EYES, THE PATIENT COMPLAINED OF BEING EXTREMELY BOTHERED BY HALOS- READ A BOOK; EXTREMELY BOTHERED BY STARBURSTS- NOT A LOT OF DRIVING; MODERATELY BOTHERED BY SENSITIVITY TO LIGHT- CANNOT WATCH TV FOR LONG PERIODS OF TIME; EXTREMELY BOTHERED BY GLARE- CANNOT RIDE IN A CAR WHEN SOMEONE ELSE IS DRIVING; VERY BOTHERED BY POOR LOW LIGHT VISION- WEARS READERS TO SEE. IT WAS LEARNED LATER ON THAT THE SUBJECT RETURNED FOR AN UNSCHEDULED VISIT. MONOCULAR UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA): 20/25 RIGHT EYE (OD), 20/25 OS; BCVA: 20/25 OD, 20/25 LEFT EYE (OS). PATIENT THIS TIME COMPLAINED OF BEING EXTREMELY BOTHERED BY HALOS- READING, NIGHT DRIVING; VERY BOTHERED BY POOR LOW LIGHT VISION- DRIVING, READING, WATCHING TV. THE SUBJECT ALSO NOTED ON THE NON-DIRECTED VISUAL SYMPTOMS COMPLAINTS OF BLURRED VISION OVERALL AND DECREASED DISTANCE VISION IN BOTH EYES. NO SURGICAL INTERVENTION WAS PLANNED DURING THAT TIME. HOWEVER, A FEW WEEKS LATER, THE SUBJECT RETURNED FOR A

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

  MAUDE report 11143785 ↗
• InjuryJun 23, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019 AND LENS WAS MISALIGNED. AT IMPLANT, OS IOL AXIS PLACEMENT WAS 178. AT SIX (06) MONTHS, IT WAS REPORT OS IOL AXIS WAS 15. NO SECONDARY SURGICAL INTERVENTION IS PLANNED AT THIS TIME. AT ONE (01) YEAR STUDY VISIT, VISUAL SYMPTOM QUESTIONNAIRE INDICATES THE PATIENT BEING EXTREMELY BOTHERED BY HALOS AND WILL NOT DRIVE AT NIGHT, EXTREMELY BOTHERED BY STARBURSTS, MODERATELY BOTHERED BY MULTIPLE OR DOUBLE VISION, VERY BOTHERED BY SENSITIVITY TO LIGHT, EXTREMELY BOTHERED BY GLARE RELATED TO SCATTERED LIGHT, VERY BOTHERED BY OCCLUSIONS, EXTREMELY BOTHERED BY POOR LOW LIGHT VISION. VISUAL SYMPTOM QUESTIONNAIRE ALSO INDICATES PATIENT REPORTED THIS IS WRONG PRESCRIPTION LENS. ONE (01) YEAR VISUAL ACUITY (VA) WAS REPORTED AS: OS UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) 20/40 AND OS BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) 20/25. PREOP VA WAS REPORTED AS: OS UCDVA 20/50 AND OS BCDVA 20/30. THE SUBJECT HAS COMPLETED THE STUDY. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE IOL IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). A SEPARATE REPORT WILL BE FILED FOR T

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 10182788 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXT225 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE ZXT225 LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINT OF ANISOMETROPIA. IT WAS REPORTED THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9583615 ↗
• InjuryDec 26, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE PATIENT THAT HE UNDERWENT BILATERAL ZXT225 INTRAOCULAR LENS (IOLS) IMPLANTS. THIS REPORT CAPTURES THE EVENT FOR THE LEFT EYE. THE LEFT EYE IOL WAS RE-ALIGNED BY THE DOCTOR ON (B)(6) 2019, POST IMPLANT, BUT THE PATIENT IS STILL HAVING SYMPTOMS. THE PATIENT CONSULTED HIS DOCTOR ABOUT THE ISSUES AS HE IS STILL UNHAPPY. PATIENT IS ALSO CONSIDERING OBTAINING A SECOND OPINION. THROUGH FOLLOW-UP THE PATIENT CLARIFIED HIS VISION IS FINE EXCEPT FOR HALOS AND GLARES WHICH MAKES HIM UNCOMFORTABLE. HE ALSO REPORTS SEEING BRIGHT FLASHES DURING THE DAY WHEN LOOKING AT LIGHT, AND HALOS WHILE WATCHING TELEVISION. HE HAS AN ACTIVE LIFE AND NOW HE FEELS RESTRICTED BECAUSE OF HIS VISUAL ISSUES. HIS DOCTOR SUGGESTED THAT HE WAIT A WHILE AS HIS BODY MUST ADAPT TO THE IMPLANTS. BUT THE PATIENT FEELS HIS VISUAL ISSUES ARE GETTING WORSE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9521955 ↗
• InjuryApr 2, 2019Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC OF THE ZXT225 MULTIFOCAL IOL (INTRAOCULAR LENS) WAS OBSERVED CRACKED DURING IMPLANTATION INTO THE PATIENT'S OPERATIVE EYE. IT WAS NOTED THAT A NON-JOHNSON AND JOHNSON CARTRIDGE WAS USED TO IMPLANT THE LENS. REPORTEDLY, THE INCISION WAS ENLARGED BUT NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. A BACK-UP LENS WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTEDLY DOING FINE POST-OP. THE ACCOUNT COMMENTED THAT THE LENS IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8472805 ↗
• MalfunctionFeb 24, 2019Break; Break

  INITIALLY, IT WAS REPORTED THAT THE ZXT225 INTRAOCULAR LENS (IOL) HAD AN ISSUE WHEN REMOVING FROM THE PACKAGING; HOWEVER, CUSTOMER DOES NOT KNOW HOW TO DESCRIBE IT IN DETAIL. THE PRODUCT WAS RECEIVED AT THE MANUFACTURING SITE WHERE PRODUCT TESTING WAS PERFORMED. THE INVESTIGATOR NOTES HAPTIC DAMAGE. THE OUTCOME OF THE INVESTIGATION HAS MET THE REPORTABLE MALFUNCTION CRITERIA; THUS, REPORTING IS REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8365120 ↗
• InjuryMay 23, 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 INTRAOCULAR LENS, MODEL ZXT150 AND IT WAS EXPLANTED. THE LENS WAS REPLACED WITH A MODEL ZCT225. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7535950 ↗
• InjuryMar 1, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE TORIC INTRAOCULAR LENS WAS EXPLANTED DUE TO AN UNSPECIFIED, QUESTIONABLE PRODUCT PROBLEM AS REPORTED BY THE DOCTOR. THE LENS WAS SWITCHED OUT WITH A DIFFERENT MODEL, DIOPTER AND CYLINDER POWER LENS WITH A MODEL ZXT150, 19.5 DIOPTER. NO INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7307212 ↗
• InjuryAug 28, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL ZXT225 19.0 DIOPTER, WAS EXPLANTED ON (B)(6)2017, DUE TO AN UNSPECIFIED LENS MALFUNCTION. THE LENS WAS REPLACED WITH A DIFFERENT MODEL, ZCB00, 19.0 DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6826150 ↗
• MalfunctionAug 22, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS NOT INSIDE THE NORMAL CONTAINER AREA, AND IT SEEMED GLUED TO THE BACK OF THE IOL CONTAINER. THE ISSUE WAS NOTICED WHEN REMOVING THE IOL FROM THE PACKAGING. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED WITH THE PRODUCT RETURN INDICATING THAT THE IOL WAS DAMAGED. THE RETURNED IOL WAS INSPECTED AND WAS OBSERVED TO BE SCRATCHED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6809411 ↗
• InjuryFeb 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DURING THE INITIAL PROCEDURE. DURING PHACO, THE CAPSULE BROKE. THIS AFFECTED THE PATENT'S LEFT EYE. THE IMPLANTED SYMPHONY LENS WAS NOT TO BLAME. THE LENS WAS INSERTED, THE INCISION ENLARGED, VITRECTOMY PERFORMED, AND SUTURES WERE USED. THERE WAS NO POST-OP PATIENT INJURY REPORTED.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 6295407 ↗