TECNIS IOL ZA9003 (REF ZA90030125)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474528864), received between Oct 16, 2018 and Jan 3, 2023 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 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.

• MalfunctionJan 3, 2023Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WHEN BEING INSERTED INTO THE PATIENT'S RIGHT EYE, WAS PARTIALLY INSERTED AND REMOVED, LEAD HAPTIC VIEWED UNDER THE MICROSCOPE, AND THERE WAS FOLDING ISSUE, BENT HAPTIC. BACK-UP IOL USED. NO PATIENT INJURY. PATIENT FINE POST-OP. NO OTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091684 ↗
• MalfunctionAug 29, 2022Break; Break

  IT WAS REPORTED THAT A DEFECT WAS NOTED IN THE OPTIC OF THE INTRAOCULAR LENS (IOL) AT THE LEADING OPTIC-HAPTIC JUNCTION. ISSUE WAS OBSERVED AS LENS WAS INSERTED INTO PATIENT'S RIGHT EYE. THE LENS WAS BISECTED AND REMOVED DURING THE SAME PROCEDURE. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT IOL AND IT WAS NOTED TO BE INTACT. THERE WAS NO PATIENT INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316809 ↗
• InjuryFeb 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE PATIENT (PT) THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD), VISION WAS CLEAR, BUT METAMORPHOPSIA WAS EXPERIENCED. OBJECTS APPEARED ¿BULGING,¿ LOOKING CLOSER AND LARGER THAN THEY REALLY WERE. VISUAL ISSUES WERE FIRST NOTICED THE DAY AFTER SURGERY, INCLUDING VARYING SIZES OF WAVES IN HORIZONTAL AND VERTICAL LINES. THE PT HAD NO METAMORPHOPSIA PRIOR TO THE INITIAL SURGERY. THE PT NOTED A LARGE INCREASE IN FLOATERS FROM WHAT PREVIOUSLY EXISTED AND OTHER ISSUES NOTED WERE ¿EXCESSIVE BLUE SHIFT¿ AND OVERALL LOOK OF AN ACRYLIC LENS VERSUS GLASS. THE SURGEON HAD DIFFICULTY REMOVING THE CATARACT AND A NON-JOHNSON AND JOHNSON CAPSULAR TENSION RING WAS IMPLANTED. THE PT REPORTED NO CAPSULE TEAR. THE SURGEON DETERMINED THAT THE ZONULES WERE TOO WEAK TO SUPPORT THE BAG IN THE PT¿S LARGE EYE, SO THE SURGEON PLACED THE IOL IN THE CILIARY SULCUS. THE IOL ¿SLIPPED¿ IN THE EYE, NOTED ON (B)(6) 2021, BUT NO ATTEMPT WAS MADE TO REPOSITION IT. THE IOL WAS EXPLANTED BY A RETINA SPECIALIST (RS), WHO TOOK OVER WHEN IT WAS DECIDED A VITRECTOMY WAS NEEDED. A NON-JOHNSON AND JOHNSON LENS (MODEL CZ70BD, 10.0 DIOPTER) WAS PLACED. THE CAPSULAR TENSION WAS NOT R

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

  MAUDE report 13589143 ↗
• InjuryFeb 14, 2022Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) BENT OVER INCORRECTLY DURING IMPLANTATION. THERE WAS CONTACT WITH PATIENT'S LEFT EYE THAT IT WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. VITRECTOMY AND SUTURES WERE REQUIRED. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH PATIENT'S ACTIVITIES OF DAILY LIFE. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13530441 ↗
• MalfunctionJun 4, 2020Break; Break

  IT WAS REPORTED THAT UPON INSERTION OF THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S LEFT EYE THE HAPTIC WAS BENT. THE DOCTOR USED THE YAMANE TECHNIQUE TO IMPLANT THE IOL. THE IOL WAS REMOVED AND REPLACED WITHIN THE SAME PROCEDURE. THERE WERE NO COMPLICATIONS SUCH AS VITRECTOMY, SUTURES OR INCISION ENLARGEMENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NON J&J IOL. REPORTEDLY, THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10121040 ↗
• InjuryJul 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CATARACT PROCEDURE, A CAPSULAR TEAR OCCURRED RESULTING IN A VITRECTOMY PROCEDURE. IT WAS REPORTED THE SURGEON MADE AN ERROR AND REALIZED A LARGER WOUND/INCISION WAS REQUIRED. THE PLANNED ZA9003 INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED IN THE SAME PROCEDURE.

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

  MAUDE report 8836336 ↗
• MalfunctionOct 16, 2018Break; Break

  IT WAS REPORTED INTRAOCULAR LENS (IOL) MODEL ZA9003 WITH 12.5 DIPOTER WAS INSERTED INTO THE PATIENT'S OPERATIVE EYE AND THE HAPTIC BROKE OFF. THE IOL WAS REMOVED BY CUTTING THE LENS IN HALF. THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME MODEL AND DIOPTER SIZE LENS AS A REPLACEMENT. THE PATIENT OUTCOME WAS REPORTED AS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7972045 ↗