TECNIS IOL ZA9003 (REF ZA90030250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05050474529113), received between Jun 15, 2017 and Sep 26, 2023 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2023Break; Break

  IT WAS REPORTED THAT THE HAPTIC WAS FOUND BROKEN AFTER THE 3-PIECE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S EYE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER IOL OF THE SAME MODEL. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17822111 ↗
• InjurySep 7, 2023Break; Difficult to Insert; Device Dislodged or Dislocated; Break; Difficult to Insert; Device Dislodged or Dislocated

  IT WAS REPORTED THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WOULD NOT FIT IN THE SULCUS CORRECTLY, THE HAPTIC KEPT STICKING OUT. THE DOCTOR DID NOT LIKE THE WAY IT FIT INTO THE PATIENT¿S RIGHT EYE. ON THE SAME DAY BUT A SEPARATE PROCEDURE, THE IOL WAS EXPLANTED AND ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND 20.5 DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WERE NO DEBILITATING SYMPTOMS RESULTING FROM THIS EVENT. AN UNPLANNED VITRECTOMY WAS REQUIRED. REPORTEDLY, THERE WAS NO CAPSULE TEAR OR SUTURES. POST OPERATIVELY THE PATIENT WAS REPORTED TO BE DOING "GREAT". NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17704292 ↗
• InjuryApr 26, 2023Break; Break

  IT WAS REPORTED THAT THE TRAILING HAPTIC BROKE DURING IMPLANTATION OF THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE. THE IOL WAS FULLY INSERTED AND THEN REMOVED. ACCOUNT INDICATED THAT INCISION WAS ENLARGED AND VITRECTOMY WAS PERFORMED. SUTURES WERE PLACED AND PATIENT RECEIVED MEDICATIONS. PATIENT STATUS PROVIDED AS TEMPORARILY IMPAIRED WITH DAILY ACTIVITIES SIGNIFICANTLY AFFECTED. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16817705 ↗
• MalfunctionMar 2, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT DURING IMPLANTATION OF INTRAOCULAR LENS (IOL) INTO THE PATIENT'S LEFT EYE, IOL WAS FULLY IMPLANTED THEN REMOVED AND REPLACED DURING THE SAME PROCEDURE DUE TO FOLDING ISSUES. ANOTHER LENS OF SAME MODEL AND SAME DIOPTER SIZE POWER WAS USED TO COMPLETE THE PROCEDURE. NO OTHER ADVERSE EVENTS. PATIENT FINE POST-OP. REPORTEDLY, EVENT MAY HAVE BEEN UNFOLDING ISSUE MORE THAN FOLDING ISSUE BECAUSE LENS WAS ACTUALLY INSERTED. THE DOCTOR HAD CONCERNS SO HE REMOVED THE IOL AND REPLACED WITH BACK-UP IOL. IT WAS NOTED THAT EXTRA MANEUVER DONE TO REMOVE THE IOL IN THAT A MACKOOL FORCEPS WAS USED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16474554 ↗
• MalfunctionNov 7, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE LENS WAS PARTIALLY INSERTED AND REMOVED DURING THE SAME PROCEDURE, AS THE TRAILING HAPTIC BROKE OFF IN THE PATIENT¿S RIGHT EYE. THERE WAS A 5-MINUTE DELAY IN THE PROCEDURE. THERE WERE NO SURGICAL AND/OR MEDICAL INTERVENTIONS AND NO PATIENT INJURY REPORTED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749466 ↗
• MalfunctionMar 29, 2022Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS BROKEN. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE HAPTIC BROKE DURING INJECTION. THE IMPLANT WAS REMOVED AND THAT THERE WAS PATIENT CONTACT WITHOUT CONSEQUENCE FOR THE PATIENT. THE PRODUCT IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935232 ↗
• MalfunctionMar 11, 2021Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT A ZA9003 MODEL INTRAOCULAR LENS(IOL) WAS FULLY IMPLANTED AND REMOVED IN THE SAME PROCEDURE DUE TO LENS BEING LOADED BACKWARDS. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF SAME MODEL AND DIOPTER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11467182 ↗
• InjuryJan 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED FROM A PATIENT'S LEFT EYE DUE TO CORNEAL EDEMA, VITREOUS PROLAPSE AND DISPLACEMENT OF THE LENS. THE INCISION WAS ENLARGED, VITRECTOMY WAS PERFORMED, AND SUTURES WERE REQUIRED. THE DATE THE SYMPTOMS FIRST WERE NOTED IS UNKNOWN. THE PATIENT WAS REPORTED TO BE FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; Vitreous Loss

  MAUDE report 11122147 ↗
• InjuryAug 6, 2020Break; Break

  IT WAS REPORTED THAT A TECNIS MONOFOCAL INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DURING THE INITIAL PROCEDURE DUE TO A BROKEN HAPTIC UPON INSERTION. SUTURES WERE USED TO COMPLETE THE PROCEDURE. REPORTEDLY, THE PATIENT IS DOING FINE POST SURGERY. THE CUSTOMER ALSO INDICATED THAT THE LENS WAS DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10376675 ↗
• MalfunctionOct 3, 2018Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS, WITH PATIENT CONTACT, TORE WHILE INSERTING THE LENS INTO THE EYE. THERE WAS NO PATIENT INJURY REPORTED AND NO INCISION ENLARGEMENT REQUIRED. PATIENT HAS RECOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7931551 ↗
• MalfunctionMar 8, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS SCRATCHED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 7325890 ↗
• MalfunctionFeb 16, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZA9003 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS NOTICED ''PITTED'' DURING HANDLING AND PRIOR TO INSERTION WITH NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7279173 ↗
• InjuryNov 17, 2017Break; Break

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF A ZA9003 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS NOTICED SEVERED DURING IMPLANTATION INTO THE PATIENT'S RIGHT EYE (OD). REPORTEDLY, THE LENS WAS MOSTLY INSERTED INTO THE PATIENT'S EYE. THE LENS WAS REMOVED AND IT WAS REPORTED THAT THE LEADING HAPTIC POPPED OFF DURING THE REMOVAL OF THE LENS. THERE WAS REPORTEDLY AN INCISION ENLARGEMENT PERFORMED. THE LENS WAS REPLACED WITH THE SAME MODEL AND DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7043228 ↗
• MalfunctionJun 15, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD SOME SORT OF FILM ON IT THAT LOOKED LIKE A SHEEN. THE SURGEON NOTICED IT AS SOON AS THE IOL WAS INJECTED INTO THE EYE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6645742 ↗