TECNIS IOL ZXT300 (REF ZXT300U215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474606418), received between Jan 13, 2017 and May 14, 2021 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED OF A 10-DEGREE ROTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE OF A PATIENT IN AN UNMASKED CLINICAL STUDY. NO REPOSITIONING OF THE IOL HAS BEEN PERFORMED AND NO INTERVENTION IS PLANNED. THE VISUAL SYMPTOMS REPORTED ON BOTH EYES OF THE PATIENT. REPORTEDLY, THE SYMPTOMS SIGNIFICANTLY IMPACT THE PATIENT¿S DAILY ACTIVITIES. THERE WERE NO SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. PREOPERATIVE VISIT: ON (B)(6) 2020. VISUAL ACUITY: UCDVA FOR RIGHT EYE (OD) 20/150 AND FOR LEFT EYE (OS) 20/30; BCDVA OD 20/50, OS 20/25. 1 WEEK STUDY VISIT: ON (B)(6) 2020. RIGHT EYE. IMPLANT WAS PLACED AT 102 DEGREES AND REPORTED AT 92 DEGREES DURING THE 1-WEEK VISIT. THERE WAS NO INTERVENTION REPORTED. 1 MONTH STUDY VISIT: ON (B)(6) 2021. UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) FOR BOTH EYES (OU): 20/20; BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA FOR BOTH EYES (OU): 20/20. THE SUBJECT REPORTED OF BEING MODERATELY BOTHERED BY HALOS; READING COMPUTER SCREEN BRIGHT LIGHTS (INDOOR/OUTDOOR) CAUSE FATIGUE/MILD HEADACHES; MODERATELY BOTHERED BY STARBURSTS-DRIVING; VERY BOTHERED BY SENSITIVITY TO

  Patient problems: Blurred Vision; Flashers; Halo; Headache; Visual Disturbances

  MAUDE report 11828506 ↗
• MalfunctionAug 24, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A CLINICAL STUDY SUBJECT NOTED A LENS AXIS MISALIGNMENT OF 10 DEGREES. THE LENS AXIS PLACEMENT WAS 175. THE LENS AXIS PLACEMENT BECAME 005. PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) WAS: 20/40 RIGHT EYE (OD); 20/40 LEFT EYE (OS). VISUAL ACUITY NOT CAPTURED AT 1 WEEK VISIT. NEVERTHELESS, NO PLAN FOR INTERVENTION. THERE WAS NO OTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10445552 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXT300 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENTS RIGHT EYE DUE TO VISUAL DISTURBANCE. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT REQUIRED, AND THE EXPLANTED LENS WAS REPLACED WITH A MODEL ZMA00 IOL. CURRENT PATIENT STATUS NOTED AS PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9478861 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXT300 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S LEFT EYE BUT WAS PLANNED TO BE EXPLANTED ABOUT FOUR (4) MONTHS LATER DUE TO THE PATIENT BEING UNHAPPY AND EXPERIENCING POSITIVE DYSPHOTOPSIA, CONTINUOUS SPARKLING VISION, HALOS, AND ADDITIONAL COMMENTS WERE MINIMAL REFRACTIVE ERROR. HOWEVER, IT WAS LEARNED THAT THE PLANNED EXPLANT WAS CANCELED FOR UNKNOWN REASON. VISUAL ACUITY PRE-OPERATIVE: 20/40 RIGHT EYE (OD), 20/25 LEFT EYE (OS). VISUAL ACUITY POST-OPERATIVE: 20/25 BOTH EYES (OU). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9211579 ↗
• InjuryApr 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXT300 21.5 DIOPTER IOL MODEL WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. PATIENT COMPLAINS OF BEING VERY BOTHERED BY STARBURSTS THAT ARE CAUSING HIM DIFFICULTY DRIVING. IT WAS ALSO REPORTED THE STARBURST SYMPTOMS DO INTERFERE WITH DAILY ACTIVITIES. THE LENS REMAINS IMPLANTED IN THE PATIENT¿S EYE. AT THIS TIME THERE ARE NO PLANS FOR ANY SURGICAL OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. THE PATIENT HAS BILATERAL LENS IMPLANTS. THE REPORT CAPTURES THE LENS IMPLANTED IN THE PATENT'S OCULAR SINISTER - LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE PATENT'S RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 8489749 ↗
• InjuryNov 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 21.5 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 EXPERIENCED ''BLURRY VISION, NOT DISTANCE AND NEAR." THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A ZCT400 21.0 DIOPTER LENS. THE PATIENT IS REPORTED TO BE DOING WELL POST EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 8086213 ↗
• InjuryJan 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL SYMFONY INTRAOCULAR LENS IMPLANTS. MODEL ZXT 300 WERE IMPLANTED IN BOTH EYES. AFTER IMPLANTATION THE PATIENT EXPERIENCED STARBURSTS IN BOTH EYES. PATIENT DID HAVE 1 DIOPTER OF RESIDUAL ASTIGMATISM IN THE RIGHT (DOMINANT) EYE GIVING UNCORRECTED VISUAL ACUITY (UCVA) OF 20/25 AND 20/20 UCVA IN THE LEFT EYE. PATIENT'S VISION REMAINS THE SAME WITH MINIMAL RESIDUAL CORRECTION IN PLACE (BEST-CORRECTED). PATIENT'S NEAR VISION IS GOOD AT J2 IN BOTH EYES. PATIENT IS HAPPY WITH HER NEAR VISION. THEY EXPLANTED THE ZXT 300 IN THE RIGHT EYE AND REPLACED IT WITH A ZXT 400 TO CORRECT THE RESIDUAL ASTIGMATISM AND HOPEFULLY REDUCE THE DYSPHOTOPSIA. PATIENT IS 20/40 1 DAY POST. THIS REPORT WILL CAPTURE THE ZXT IOL EXPLANTED FROM THE RIGHT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 6251889 ↗