TECNIS IOL ZA9003 (REF ZA90030145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474528901), received between Jun 22, 2017 and May 15, 2023 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) HAPTIC BROKE OFF DURING INSERTION INTO THE LEFT EYE AND THE LENS WAS REMOVED AND REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL (SAME MODEL, DIFFERENT DIOPTER, 14.0) DURING THE SAME PROCEDURE. AN INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING WELL POST-OPERATIVE. BALANCED SALT SOLUTION (BSS) WAS USED AND WAS AT ROOM TEMPERATURE. IT WAS NOTED THAT THE CUSTOMER THINKS THIS ISSUE MAY HAVE OCCURRED BECAUSE THE HAPTICS ARE VERY THIN AND FRAGILE. THE LENS WAS NOT POSITIONED CLOSER TO THE TIP OF THE CARTRIDGE THAN NORMAL. THE PRODUCT IS NOT AVAILABLE TO BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16934601 ↗
• MalfunctionApr 1, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE, HOWEVER, WAS REMOVED DURING THE SAME PROCEDURE DUE TO BROKEN HAPTIC. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13972532 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DISLOCATED POST IMPLANTATION IN THE LEFT EYE. THROUGH FOLLOW-UP, THE CUSTOMER CLARIFIED THAT THE ACTUAL CAUSE OF SUBLUXATION WAS PSEUDOEXFOLIATION WITH ZONULAR LOSS. THE LENS MOVED ON ITS OWN SPONTANEOUSLY. THE SURGEON EXPLANTED THE LENS DURING SECONDARY SURGERY AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND HIGHER DIOPTER) WITH SCLERAL FIXATION. 1 DAY POST-OPERATIVE (OP) EXAM SHOWED BLURRED VISUAL ACUITY (VA) DUE TO CIRCULATING HYPHEMA. VISION ACUITY PRE-OP IS 20/30, POST OP IS UNKNOWN. THERE IS NO TRAUMA TO THE EYE. THE PATIENT RECEIVED PRESCRIPTIVE MEDICATION; HOWEVER, DETAILS NOT PROVIDED. THE PATIENT CURRENT STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT CAPTURES THE REPLACEMENT LENS, MODEL, ZA9003 14.5D. A SEPARATE REPORT IS BEING SUBMITTED FOR THE EXPLANTED LENS, MODEL ZA9003 14.0D REPORTED EVENT.

  Patient problems: Blurred Vision; Hyphema

  MAUDE report 13972310 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS UNHAPPY WITH THE INTRAOCULAR LENS (IOL) IMPLANTED IN THE RIGHT (OD) EYE AS PATIENT SEES GLARE AND HALOS POST-OP. THE IOL THEN WAS EXPLANTED REQUIRING INCISION ENLARGEMENT AND THE SUSPECT IOL WAS REPLACED WITH THE SAME MODEL BUT HIGHER DIOPTER POWER, 17.5. THERE IS NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 11340803 ↗
• InjuryJan 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS WAS EXPLANTED FROM PATIENT LEFT EYE DUE TO UNHAPPY WITH POST-OP OUTCOME. THERE WAS INCISION ENLARGEMENT. NO SUTURES OR VITRECTOMY WERE REQUIRED. LENS WAS IMPLANTED WITH A NON-JOHNSON AND JOHNSON LENS, 14.0DIOPTER POWER AS REPLACEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 11205934 ↗
• InjuryMay 14, 2019Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) LENS HAD A DAMAGED OR BROKEN HAPTIC. THERE WAS PATIENT CONTACT, HOWEVER, NO PATIENT INJURY. THE LENS WAS NOT FULLY INSERTED. THE INCISION WAS ENLARGED, BUT THERE WAS NO VITRECTOMY. PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP LENS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8606540 ↗
• MalfunctionJan 14, 2019Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS HAD TORN OR BROKEN HAPTIC. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8246767 ↗
• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT A ZA9003 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO HER RIGHT EYE (OD) ON (B)(6) 2017. POST-OPERATIVELY, THE DAY AFTER SURGERY, THE PATIENT EXPERIENCED SEEING HALOS. ALSO, THE PATIENT STATED THAT HER PUPILS ARE MORE DILATED THAN TYPICAL AND WONDERED IF THIS WAS THE CAUSE OF THE HALOS. REPORTEDLY, THE PATIENT HAD ASTIGMATISM PRE-OPERATIVELY AND STILL HAS THIS POST-OPERATIVELY. THE LENS MAY BE EXPLANTED AND REPLACED, BUT SHE IS CURRENTLY DOING RESEARCHING TO FIGURE OUT IF THE EXPLANT WILL BE PERFORMED OR NOT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7287791 ↗
• MalfunctionJun 22, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT A SCRATCH WAS NOTICED ON AN INTRAOCULAR LENS (IOL), ONCE INSERTED INTO THE PATIENT'S EYE. REPORTEDLY, THE LENS WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6659449 ↗