TECNIS IOL ZA9003 (REF ZA90030230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 05050474529076), received between Aug 31, 2016 and Oct 11, 2024 — classified as 21 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2024Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE/ BROKEN. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20434143 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS HAD BEEN EXPLANTED BECAUSE OF UNRESOLVED DYSPHOTOPSIA. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER COMPANY LENS. THERE WAS NO INJURY, AND SURGICAL AND MEDICAL INTERVENTIONS ARE REQUIRED. THE PATIENT POST STATUS IS UNKNOWN. THE PRODUCT IS BEING RETUNED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 19112362 ↗
• MalfunctionDec 21, 2023Scratched Material; Scratched Material

  THE SURGERY CENTER REPORTED SCRATCHED INTRAOCULAR LENS (IOL) UPON OPENING THE BOX. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18374618 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AND CONFIRMED THAT AN INTRAOCULAR LENS (IOL) WITH NO QUALITY ISSUE WAS EXPLANTED. THE SPECIFIC REASON FOR EXPLANT IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 18166362 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S RIGHT EYE DUE TO NEGATIVE DYSPHOTOPSIA. A NON-JOHNSON AND JOHNSON LENS OF +22.5 DIOPTER WAS USED AS A REPLACEMENT. THERE WAS NO UNPLANNED VITRECTOMY PERFORMED, NO MEDICAL INTERVENTIONS, NO UNPLANNED INCISION ENLARGEMENT, AND NO UNPLANNED SUTURES REQUIRED. NO DELAY IN PROCEDURE REPORTED AND NO PATIENT INJURY INDICATED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 17954509 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO PATIENT HAVING DIFFICULTY DRIVING, RECOGNIZING PEOPLE AND FEELS HER READING VISION IS TOO CLOSE. THERE WERE NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES PERFORMED. THE EXPLANTED LENS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THE PATIENT FULLY RECOVERED POST-EXPLANT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 17761168 ↗
• MalfunctionAug 18, 2023Break; Break

  IT WAS REPORTED THAT THE TECNIS MONOFOCAL INTRAOCULAR LENS HAD A BROKEN HAPTIC WHICH WAS OBSERVED DURING HANDLING PRIOR TO INSERTION. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION CONFIRMED THAT THERE WAS PATIENT CONTACT AND STATED THAT THE LENS WAS LOADED INTO A CARTRIDGE AND INJECTED INTO THE EYE. AT THIS STAGE AS IT CAME THROUGH THE CARTRIDGE IT WAS NOTED TO HAVE A BROKEN HAPTIC SO IT WAS REMOVED FROM THE PATIENTS EYE AND A NEW LENS WAS USED. THE PRODUCT IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17574031 ↗
• MalfunctionAug 13, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED AFTER THE ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S OPERATIVE EYE, THE SURGEON NOTED THE TRAILING HAPTIC WAS DETACHED FROM THE IOL. THE IOL WAS CUT IN HALF AND REMOVED AND ANOTHER IOL WAS LOADED AND INSERTED WITHOUT INCIDENT; MODEL AND DIOPTER INFORMATION IS UNKNOWN. PATIENT STATUS POST-PROCEDURE IS ALSO UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538119 ↗
• MalfunctionMar 20, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) LEADING HAPTIC WAS DAMAGED DURING IMPLANTATION INTO THE PATIENT'S EYE. THE IOL WAS PARTIALLY INSERTED WHEN THE ISSUE OCCURRED. THE LENS WAS REMOVED FROM THE EYE. THERE WAS NO HARM TO THE PATIENT. THERE WAS NO SURGICAL OR MEDICAL INTERVENTION PERFORMED. THE IOL IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573871 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S LEFT EYE, THEY EXPERIENCED SUBJECTIVE VISUAL DISTURBANCES. IT IS UNKNOWN IF THE SYMPTOMS WERE AFFECTING THE PATIENT¿S DAILY ACTIVITIES. THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS. THE INCISION WAS ENLARGED. SUTURES WERE NOT REQUIRED AND NO MEDICATION WAS PRESCRIBED. REPORTEDLY, THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 16380824 ↗
• InjuryNov 28, 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 EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO OTHER DISORDERS OF THE EYE FOLLOWING CATARACT SURGERY. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 15874490 ↗
• InjuryNov 3, 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 EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO REFRACTIVE SURPRISE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES DONE. THE EXPLANTED IOL WAS REPLACED WITH DIU225 22.5D POWER SIZE IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15722735 ↗
• MalfunctionNov 1, 2022Break; Break

  IT WAS REPORTED THAT THE DOCTOR INSERTED A NON-PRELOADED INTRAOCULAR LENS (IOL) AND FOUND THE TRAILING HAPTIC TO BE KINKED. DOCTOR WOULD LIKE TO DO AN IOL EXCHANGE; HOWEVER, THEY HAVE LEFT THE IOL IN THE PATIENT¿S EYE TO SEE IF ISSUE WILL RESOLVE. THERE WAS NO PATIENT INJURY REPORTED. PATIENT IS BEING MONITORED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712598 ↗
• InjurySep 19, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER SETTING ZA9003 23.0D INTRAOCULAR LENS (IOL) TO BE IMPLANTED, ITS LEAD HAPTIC HAD COME OFF FROM THE BASE IN THE CAPSULE. THE REPORTING PHYSICIAN DID NOT FEEL SOMETHING WRONG WITH IT AT THE TIME OF SETTING. THE LENS AND HAPTIC WERE REMOVED FROM THE EYE BY OPENING UP THE INCISION WOUND TO ABOUT 6 MM WIDE, AND THEN, ANOTHER ZA9003 (SERIAL UNKNOWN), WHICH WAS THE BACK-UP LENS WAS IMPLANTED. THE OPERATIVE DURATION WAS EXTENDED BY 15 MINUTES. NO INJURY HAD DEVELOPED DURING SURGERY. NO POSTOPERATIVE HEALTH DAMAGE HAD DEVELOPED. THERE WAS NO PATIENT INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 15450979 ↗
• MalfunctionAug 10, 2022Contamination; Contamination

  IT WAS REPORTED THAT AFTER IMPLANTING THE INTRAOCULAR LENS (IOL), THE SURGEON SAW IN THE EYE THAT THERE WERE DARK "FIBERS" OR SIMILAR INTEGRATED INTO THE HAPTICS AT THE BOTTOM. THESE COULD NOT BE REMOVED BY SUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15204757 ↗
• MalfunctionJun 21, 2022Break; Break

  IT WAS REPORTED THAT AS THE INTRAOCULAR LENS (IOL) WAS BEING INSERTED INTO THE CAPSULAR BAG OF THE PATIENT'S OPERATIVE EYE, THE TRAILING HAPTIC WAS NOTED TO BE FRACTURED. THE LENS WAS BISECTED AND EXPLANTED. A NEW LENS WAS INJECTED AND NOTED TO BE INTACT AND WELL CENTERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14758234 ↗
• MalfunctionApr 20, 2022Break; Break

  IT WAS REPORTED UPON INSERTION INTO THE PATIENT'S OPERATIVE EYE THE HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS NOTED TO BE BENT. THE CARTRIDGE TIP DID TOUCH THE PATIENT'S EYE BUT THE LENS DID NOT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164486 ↗
• MalfunctionApr 15, 2022Break; Break

  IT WAS REPORTED UPON INSERTION INTO THE PATIENT'S OPERATIVE EYE, THE HAPTIC OF AN INTRAOCULAR LENS (IOL) WAS NOTED TO BE BENT. THE CARTRIDGE TIP DID TOUCH THE PATIENTS EYE, BUT THE LENS DID NOT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14122683 ↗
• MalfunctionMar 3, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD BENT HAPTIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664687 ↗
• MalfunctionFeb 8, 2022Break; Difficult to Fold, Unfold or Collapse; Break; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE LEADING HAPTIC KINKED AND BECAME STUCK TO THE INTRAOCULAR LENS (IOL). THE IOL WAS FULLY INSERTED INTO THE PATIENT'S EYE AND REMOVED IN THE SAME PROCEDURE. THE ACCOUNT PLANS TO USE A NON-JOHNSON & JOHNSON LENS AS A REPLACEMENT IN THE FUTURE. NO ADDITIONAL INTERVENTIONS WERE MENTIONED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13490084 ↗
• MalfunctionJan 27, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD BENT/ BROKEN HAPTIC. THERE WAS CONTACT WITH PATIENT'S RIGHT EYE AND THE ISSUE WAS NOTICED WHILE INSERTING THE LENS INTO THE EYE. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF SAME MODEL AND DIOPTER AND THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13375909 ↗
• MalfunctionJan 6, 2022Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS OBSERVED WITH A BENT/BROKEN HAPTIC AFTER IT WAS PARTIALLY INSERTED INTO THE PATIENT'S LEFT EYE. CUSTOMER INDICATED THAT THE IOL WAS REMOVED AND REPLACED WITH A BACK UP LENS (SAME MODEL AND DIOPTER) TO COMPLETE THE SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13183234 ↗
• MalfunctionNov 22, 2021Break; Failure to Fold; Scratched Material; Break; Failure to Fold; Scratched Material

  IT WAS REPORTED THAT A ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS FOLDED INCORRECTLY AND AFTER INSERTION OF THE LENS INTO THE PATIENT'S LEFT EYE, IT WAS NOTICED TO BE A BAD FOLD WHICH THE FRONT HAPTIC WAS BENT, THE TRAILING HAPTIC WAS KINKED AND THE LENS WAS SCRATCHED. THE IOL WAS REMOVED FROM THE EYE AND ANOTHER LENS OF THE SAME MODEL, BUT A DIFFERENT DIOPTER (17.0 D) WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY REPORTED AND NO OTHER INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858777 ↗
• MalfunctionNov 12, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH LOADING A ZA9003 MODEL INTRAOCULAR LENS(IOL). THE LENS WAS INSERTED, BUT THEN REMOVED DUE TO AN ISSUE WITH THE HAPTIC. THE HAPTIC DETACHED WHILE THE PHYSICIAN WAS ROTATING THE LENS IN THE EYE. THE PROCEDURE WAS COMPLETED USING ANOTHER ZA9003 LENS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807654 ↗
• InjuryOct 27, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A ZA9003 MODEL INTRAOCULAR LENS(IOL) WAS FULLY INSERTED AND HAPTIC BROKE OFF AND WAS REMOVED IN THE SAME PROCEDURE. VITRECTOMY WAS DONE DUE TO CAPSULAR TEAR, A COMPLICATION TRIGGERED BY IMPLANTING THE LENS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS OF SAME MODEL AND DIOPTER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12702499 ↗