TECNIS IOL ZXR00 (REF ZXR00U0135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474591714), received between Apr 5, 2017 and Nov 3, 2023 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE IN A SECONDARY PROCEDURE DUE TO A SUDDEN SUBLUXATION OF THE IOL. UNSPECIFIED SYMPTOMS PERSISTED FOR 7 DAYS. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (ZA9003 +14.0 DIOPTER). NO INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WAS REQUIRED. THE PATIENT IS FULLY RECOVERED. THROUGH FOLLOW UP, IT WAS REPORTED THAT IT WAS UNKNOWN IF THERE WAS ANY PATIENT INJURY. THE ACCOUNT INDICATED THAT NO FURTHER INFORMATION IS AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 18062960 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE THAT PATIENT EXPERIENCED DEFINED HALOS AND GLARE. DISTANCE IMAGES ARE CLEAR WITH RIGHT EYE (SHAPE OF LEAVES, ROAD SIGNS, ETC). THE PATIENT CAN DRIVE HOWEVER, THE PATIENT AVOIDS NIGHT DRIVING. THROUGH FOLLOW-UP WITH THE PATIENT, IT WAS LEARNED THAT THE PATIENT CURRENTLY STILL EXPERIENCES HALOS AND GLARE AROUND HOUSE LIGHTS AND ONCOMING VEHICLE TRAFFIC WITH THE RIGHT EYE. THE PATIENT HAS EXPERIENCED MORE DRY EYE SYMPTOMS AND USES OVER-THE-COUNTER LUBRICATING DROPS (SYSTANE). THE PATIENT REPORTED THAT THE VISUAL ISSUES IN THE RIGHT EYE ARE NOT AFFECTING DAILY ACTIVITIES. THE VISUAL ISSUES STARTED THE DAY AFTER SURGERY AND CLARITY IMPROVED OVER TWO TO THREE MONTHS. THE PATIENT HAD MORE DRY EYES UNTIL TWO TO THREE MONTHS POST-SURGERY. GLARE PERSISTS HOWEVER, THE PATIENT CAN DRIVE DURING THE NIGHT CAUTIOUSLY (WITH INCREASED GETTING USED TO THE LENS). AFTER COMPLETION OF THE ONE-MONTH USE OF TYPICAL POST-SURGERY EYE DROPS, THE PATIENT STILL EXPERIENCED SOME PAIN, DRYNESS, DISCOMFORT, AND THE PATIENT¿S VISION WAS BLURRY. THE DOCTOR INSTRUCTED THE PATIENT TO CONTINUE USE OF AN ADDITIONAL ONE MONTH OF STEROI

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

  MAUDE report 15097453 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED SEEING STARBURST AT NIGHT POST IMPLANTATION OF A ZXR00 MODEL INTRAOCULAR LENS (IOL) IN HIS RIGHT EYE. DOCTOR INDICATED THAT SYMPTOMS WOULD GO AWAY OVER TIME; HOWEVER, PATIENT HAS GOTTEN WORSE. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT HAS REQUESTED LENS REPLACEMENT; HOWEVER, THE DOCTOR HAS INDICATED THAT A SECONDARY SURGERY MIGHT NOT BE IDEAL. PATIENT CLARIFIED THAT THEY ARE HAVING ISSUES WITH STARBURST WHEN DRIVING AT NIGHT. EYE DROPS HAVE BEEN PRESCRIBED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Flashers

  MAUDE report 12701325 ↗
• InjurySep 24, 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 (B)(6) 2019. THE OCULAR RESPONSE ANALYZER (ORA) RECOMMENDATIONS DID NOT SUGGEST THE NEED FOR A TORIC LENS DURING ORIGINAL SURGERY. ON POST OP EXAM, (B)(6) 2019, THE PATIENT WAS MEASURING 2 DIOPTERS OF ASTIGMATISM WITH MANUAL K'S IN THE RIGHT EYE (OD). THE LENS WAS REPLACED WITH A MODEL ZXT150 13.0 DIOPTER. THERE WERE NO COMPLICATIONS AND NO INCISION ENLARGEMENT. PATIENT IS DOING WELL POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9111367 ↗
• InjuryMar 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT FOLLOWING THE IMPLANT OF A ZXR00 INTRAOCULAR LENS (IOL) IN AUGUST, SHE STILL CANNOT SEE. ADDITIONAL INFORMATION RECEIVED REVEALED THE SYMPTOMS SIGNIFICANTLY AFFECT THE PATIENT'S ABILITY TO PERFORM ACTIVITIES OF DAILY LIFE, SPECIFICALLY READING AND GLARE WHICH IS AFFECTING HER ABILITY TO DRIVE AT NIGHT. NO ADDITIONAL MEDICAL OR SURGICAL PROCEDURES BEEN PERFORMED. THE PATIENT HAS BEEN PRESCRIBED READING GLASSES. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8462730 ↗
• InjuryOct 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +13.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE OF THE PATIENT EXPERIENCING INTOLERABLE GLARE AND HALOS. THE REPLACEMENT LENS WAS A MONOFOCAL, MODEL PCB00. INCISION ENLARGEMENT WAS PERFORMED. THERE WAS NO SUTURES AND NO VITRECTOMY PERFORMED. REPORTEDLY VISUAL ACUITY PRE-OP WAS 20/30 AND VISUAL ACUITY POST-OP: 20/20. INTRAOCULAR LENS WAS EXCHANGED WITH RESOLUTIONS IN THE SYMPTOMS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8027108 ↗
• InjurySep 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +13.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING BOTHERSOME GLARE WHEN DRIVING AT NIGHT. A COMPETITOR LENS WAS USED AS A REPLACEMENT. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED, NO SUTURES WERE USED AND NO PATIENT INJURY OCCURRED. REPORTEDLY, A POSTERIOR CAPSULE YAG (YTTRIUM ALUMINUM GARNET) WAS PERFORMED. THE PATIENT¿S VISION WAS REPORTED AS IMPROVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7905282 ↗
• InjuryJun 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +13.5 DIOPTER) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE ON (B)(6) 2017. REPORTEDLY, THERE WAS A CAPSULE TEAR AND A VITRECTOMY WAS PERFORMED. RETINAL DETACHMENT OCCURRED 4 DAYS POST OP. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Retinal Detachment; Vitrectomy

  MAUDE report 7600305 ↗
• InjuryApr 27, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +13.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE IN SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING HALOS AND GLARES, BLURRY VISION, VISUAL DISTURBANCE, AND INTOLERANCE. POST IMPLANT THE LENS HAD MINOR DISLOCATION WHICH SURGEON ATTEMPTED A RELOCATION AND A LASER PROCEDURE, HOWEVER THE PATIENT WAS NOT HAPPY AND CHOSE TO GO FOR AN EXCHANGE. NON-AMO MONOFOCAL LENS WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. NO INCISION ENLARGEMENT, VITRECTOMY OR ANY OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS REPORTED TO BE DOING WELL WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 7470769 ↗
• InjuryApr 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 13.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S RIGHT EYE DUE TO A REFRACTIVE ERROR. THE PATIENT'S VISUAL OUTCOME WAS AT +1 SPHERE POST IMPLANT. THE LENS WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A SAME MODEL LENS OF A HIGHER DIOPTER (14.5). THROUGH FOLLOW-UP IT WAS LEARNED THAT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO POST-OP INJURY. FURTHERMORE, THE CUSTOMER RELATES THE REFRACTIVE ERROR TO PATIENT'S ANATOMY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6510173 ↗
• InjuryApr 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A CATARACT SURGERIES DONE (B)(6) 2016, AND (B)(6) 2017. THE PATIENT IS REPORTING THAT THEIR NEAR VISION IS NOW WORSE THEN EVER, PARTICULARLY IN THE LEFT EYE WHICH SEEMS TO HAVE DEVELOPED A PERMANENT GREY CLOUD AFFECTING BOTH NEAR AND FAR VISION. PATIENT ALSO STATED THAT THEIR NEAR VISION WAS BETTER PRIOR TO THE SURGERIES. THE PATIENT EXPECTED TO BE ABLE TO READ WITHOUT MAGNIFIERS AFTER THE LENSES WERE IMPLANTED. PATIENT HAD FOLLOW-UP APPOINTMENTS AND WAS TOLD TO GIVE IT TIME. NOTHING HAS IMPROVED SINCE THE LENSES WERE IMPLANTED. THERE HAS NOT BEEN ANY ADDITIONAL SURGICAL OR MEDICAL INTERVENTION SINCE THE IMPLANTS. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE WHICH WAS IMPLANTED ON (B)(6) 2016.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 6460824 ↗