TECNIS IOL ZA9003 (REF ZA90030210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 05050474529038), received between Sep 30, 2016 and Aug 25, 2026 — classified as 61 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (31 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50440084 ↗
• InjuryJan 13, 2026Device Dislodged or Dislocated

  THE ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). POST-OPERATIVELY, DUE TO IOL DISPLACEMENT - IOL/CAPSULE SUBLUXATED AND WAS UNSTABLE, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH AN AR40E 21.5 IOL. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. THERE WAS NO PRODUCT QUALITY ISSUE THAT CONTRIBUTED TO THE IOL EXPLANT DECISION. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 24064000 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MONOFOCAL LENS WAS EXPLANTED DUE TO ONGOING PAIN, BLURRED VISION, AND GLAUCOMA. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH A IOL FROM ANOTHER MANUFACTURER, AND THE PATIENT REQUIRED SUTURES. ADDITIONAL INFORMATION REVEALED THAT THE PATIENT EXPRESSED A DESIRE TO SEE AT A DISTANCE WITHOUT GLASSES, RATHER THAN NEAR WITHOUT GLASSES. DOCUMENTATION WAS REVIEWED TWICE, CONFIRMING THAT HIS REFRACTIVE TARGET WAS NEAR: ONCE DURING HIS INITIAL ENCOUNTER AND AGAIN ON THE NEXT VISIT. BOTH VISITS CONFIRMED WITH THE PATIENT THAT A NEAR TARGET WAS THE REFRACTIVE PLAN. THERE WAS NO INJURY TO THE PATIENT. THE PATIENT IS DOING OKAY BUT IS STILL EXPERIENCING BLURRED VISION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Eye Pain; Glaucoma

  MAUDE report 22386873 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRE-LOADED INTRAOCULAR LENS (IOL) WAS FULLY INSERTED BUT HAD TO BE CUT OUT DUE TO INSUFFICIENT SUPPORT FROM THE ANTERIOR CHAMBER. THE PROCEDURE WAS COMPLETED WITH A IOL FROM ANOTHER MANUFACTURER AND THE PATIENT REQUIRED SUTURES AND VITRECTOMY. THERE WAS NO OTHER INJURY TO THE PATIENT AND THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear; Vitreous Loss

  MAUDE report 21867255 ↗
• InjuryDec 26, 2024Adverse 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 AS THE PATIENT EXPERIENCED VISUAL DISTURBANCES SUCH AS STREAKS OF LIGHT, SEEING LENS EDGES AND HAS VISION LOSS FROM BEAMS OF LIGHT. IT IS UNKNOWN IF THE PATIENT'S DAILY ACTIVITIES WERE AFFECTED DUE TO THE REPORTED SYMPTOMS. A REPLACEMENT LENS OF DIFFERENT MODEL AND DIOPTER ( DCB00 +15.5) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD). NO UNPLANNED SURGICAL INTERVENTIONS (SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES) REPORTED. THE PATIENT HAS FULLY RECOVERED POST-OPERATION. IT IS UNKNOWN IF MEDICATION (OUTSIDE OF STANDARD CARE) PRESCRIBED OR IF THERE WAS A DELAY IN PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Visual Disturbances

  MAUDE report 21023760 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT INITIALLY REPORTED THAT HIS LEFT EYE VISION LOOKS CRACKED. HIS DOCTOR TOLD HIM TO USE EYE DROPS FOR FIVE (5) DAYS. THE PATIENT HAS PAIN IN HIS EYE, CANNOT SLEEP, DOES NOT SEE CLEAR AND STILL SEES BLURRY. IN FOLLOW UPS WITH THE PATIENT, HE INDICATED HE SEES A WHITE LIGHT ON THE SIDE OF THE EYE, HIS VISION IS BAD, THAT HE HAS PAIN IN HIS EYEBALL WITH WATERY EYE. THE PATIENT LAST SAW HIS DOCTOR TWO WEEKS AGO, BUT NO EXPLANATION WAS PROVIDED TO THE PATIENT BY HIS DOCTOR. THE PATIENT HAS BEEN GIVEN A PILL AND 10-12 EYE DROPS WHICH HE IS STILL USING THEM (THE NAME OF MEDICATIONS WAS NOT PROVIDED AS THE PATIENT DID NOT HAVE THAT INFORMATION). IT WAS CONFIRMED THAT NO LASER PROCEDURE OR OTHER SURGICAL INTERVENTIONS HAVE BEEN PERFORMED ON THE PATIENT¿S EYE. THE PATIENT INDICATED HE IS NOT ABLE TO PERFORM HIS DAILY ACTIVITIES AS HE USED TO BEFORE THE SURGERY, THAT HE CANNOT DRIVE. THE PATIENT HAS ASKED THE DOCTOR TO EXPLANT AND REPLACE THE LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Eye Pain; Unspecified Eye / Vision Problem; Visual Disturbances

  MAUDE report 19131457 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO REFRACTIVE SURPRISE. THE OUTCOME WAS NOTICED DURING A POST-OP EXAM. REPORTEDLY, THE DIRECTIONS FOR USE WERE FOLLOWED. THE EXPLANTED IOL WAS REPLACED WITH ANOTHER JNJ LENS, MODEL ZCB00 +19.5. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 18877270 ↗
• MalfunctionAug 31, 2023Break; Break

  THE SURGERY CENTER REPORTED HAPTIC BROKE, NOT INSERTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17665089 ↗
• InjuryAug 28, 2023Break; Break

  IT WAS REPORTED THE ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) AND REMOVED DUE TO BENT HAPTIC. ANOTHER BACK-UP OF THE SAME MODEL ZA9003 21.0 DIOPTER IOL WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO SERIOUS PATIENT INJURY AND NO SUTURE(S) HOWEVER, THE INCISION WAS ENLARGED AND A VITRECTOMY WAS PERFORMED. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS CURRENTLY HAND MOTION (HM). THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 17638987 ↗
• MalfunctionAug 7, 2023Scratched Material; Scratched Material

  THE SURGERY CENTER REPORTED DEFECTIVE LENS. THE LENS WAS INSERTED AND REMOVED FROM PATIENT'S LEFT EYE DURING THE SAME PROCEDURE. INCISION ENLARGEMENT WAS REQUIRED. THROUGH FOLLOW UP, IT WAS CLARIFIED THAT THAT THE LENS HAD BLEMISH, SOMETHING LIKE A TEAR ON IT. THE ACCOUNT DOES NOT KNOW IF THE PROBLEM WAS DUE TO LOADING ERROR ISSUE AND/OR IF THE LENS WAS INSPECTED PRIOR TO BEING LOADED INTO THE CARTRIDGE. NO OTHER SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS USED. A JOHNSON & JOHNSON CARTRIDGE WAS USED, BUT THE MODEL/ LOT NUMBER IS UNKNOWN. THE PATIENT OUTCOME WAS REPORTED TO BE FINE AND NO INJURY REPORTED. THE LENS WAS DISCARDED AND WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17477288 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT ZA9003 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO UNKNOWN REASON. ADDITIONAL INFORMATION REVEALED THAT ANOTHER IOL OF SAME MODEL AND DIOPTER WAS USED AS REPLACEMENT LENS. THE PRODUCT IS BEING RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 17374223 ↗
• InjuryJun 5, 2023Break; Break

  IT WAS REPORTED THAT AFTER INSERTING THE ZA9003 INTRAOCULAR LENS (IOL) IN THE PATIENTS RIGHT EYE, THE PHYSICIAN NOTICED HAPTIC DAMAGE AND TRIED TO RE-POSITION BUT WAS NOT ABLE TO DO. SHE THEN HAD TO CUT OUT IOL AND REPLACED WITH A ZCB00 LENS. ADDITIONAL INFORMATION REVELATED THAT THE INTRAOCULAR PRESSURE (IOP) DURING ONE DAY POST OP WAS 37 ON (B)(6) 2023 AND ON (B)(6) 2023 IT WAS 14. THE WOUND WAS BURPED ON (B)(6) 2023 TO DECREASE THE IOP FROM 37 TO 9. PATIENT HAD HYPEREDEMA AND DOING WELL. THERE WAS NO USE ERROR. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Intraocular Pressure Increased; Swelling/ Edema

  MAUDE report 17067164 ↗
• MalfunctionMay 17, 2023Break; Break

  IT WAS REPORTED THAT THE ZA9003 INTRAOCULAR LENS WAS FULLY INSERTED. SURGEON SAW LENS WAS CRACKED. ZA9003 LENS WAS REMOVED AND REPLACED WITH ANOTHER ZA9003 LENS OF SAME DIOPTER. IT WAS STATED THAT THE DAMAGED LENS WAS CUT AND REMOVED. PATIENT STATUS WAS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950206 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZA9003 INTRAOCULAR LENS (IOL) WAS IMPLANTED BUT REMOVED. REPLACEMENT LENS INFORMATION IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 16838037 ↗
• InjuryApr 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE FULLY INSERTED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE IN A SECONDARY PROCEDURE DUE TO DISPLACEMENT OF THE LENS, WHICH WAS OBSERVED AFTER IMPLANTATION. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME MODEL AND DIOPTER). NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURE WAS REQUIRED. NO PATIENT INJURY WAS INDICATED. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16830138 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE WHEN THE INTRAOCULAR LENS (IOL) WAS BEING INSERTED INTO THE EYE, THE LENS HAD TO BE CUT OUT AND A VITRECTOMY WAS PERFORMED. AN ANTERIOR CHAMBER LENS WAS IMPLANTED AS REPLACEMENT DURING THE SAME PROCEDURE. AN INCISION ENLARGEMENT AND SUTURES WERE ALSO REQUIRED. IT WAS NOTED THAT THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO DELAY IN PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16828608 ↗
• MalfunctionMar 14, 2023Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) TRAILING HAPTIC DID NOT FOLD PROPERLY AND WAS BENT/BROKEN IN THE PROCESS. THE ISSUE WAS NOTICED AFTER INSERTION. THE IOL WAS FULLY INSERTED IN THE LEFT EYE AND REPLACED IN THE SAME PROCEDURE WITH ANOTHER JOHNSON AND JOHNSON IOL (SAME MODEL AND DIOPTER). THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED AND NO PATIENT INJURY. THE PATIENT HAS RECOVERED. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16540295 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE PATIENT'S LEFT EYE, WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. THE SURGEON CHANGED LENS TO A DIFFERENT A NON-JOHNSON & JOHNSON LENS DUE TO EYEBALL SIZE. PSEUDOEXFOLIATIVE (PXF) RESULTED IN UNSTABLE SAC AND 40 PERCENT ZONULAR LOSS. VITRECTOMY WAS PERFORMED. CURRENT PATIENT STATUS WAS REPORTED AS UNKNOWN. THE SUSPECT IOL WAS DISCARDED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 16457279 ↗
• InjuryFeb 10, 2023Adverse 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 FULLY IMPLANTED IN THE LEFT EYE AND THEN REMOVED BECAUSE THE LENS SLIPPED INTO THE BACK OF THE EYE. THERE WAS INSUFFICIENT CAPSULE SUPPORT FOR THE PLACEMENT OF THIS LENS SO THE DECISION WAS MADE TO LEAVE THE PATIENT APHAKIC FOR A "RE-OP" WITH A DIFFERENT TYPE OF LENS. THE PATIENT HAS A HISTORY OF PSEUDOEXFOLIATION. THE PATIENT HAD DIFFUSE ZONULOPATHY. A VITRECTOMY AND SUTURES WERE REQUIRED. PLACEMENT OF SCLERAL-FIXATED LENS IS PLANNED AND THE PATIENT IS SCHEDULED FOR GLAUCOMA SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16357632 ↗
• MalfunctionFeb 7, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) TRAILING HAPTIC WAS KINKED. IT WAS INSERTED IN THE RIGHT EYE AND THEN REMOVED. NO SUTURE NEEDED. THE EVENT WAS OBSERVED AFTER INSERTION. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME MODEL AND DIOPTER). THERE WAS NO PATIENT INJURY. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16309886 ↗
• InjuryFeb 6, 2023Adverse 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 A PATIENT¿S RIGHT EYE DUE TO DYSPHOTOPSIA. IT WAS INDICATED THAT THE SYMPTOMS PERSISTED FOR ONE YEAR. THERE WAS NO DELAY IN PROCEDURE AND NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE COMPLETED SUCCESSFULLY USING A NON-JOHNSON AND JOHNSON LENS OF +20.5 DIOPTER. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 16308581 ↗
• InjuryJan 26, 2023Adverse 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 BECAUSE OF DYSPHOTOPSIA. A NON-JOHNSON AND JOHNSON LENS OF +21.0 DIOPTER WAS USED AS THE REPLACEMENT. NO OTHER SURGICAL INTERVENTIONS WERE INDICATED, AND NO MEDICATION WAS PRESCRIBED. REPORTEDLY, THE PATIENT SYMPTOMS PERSISTED FOR FIVE (5) WEEKS. THE PATIENT FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 16248340 ↗
• InjuryJan 19, 2023Adverse 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 FROM PATIENT'S LEFT EYE DUE TO VISION DISTURBANCES. NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT HAS FULLY RECOVERED.

  Patient problems: Visual Disturbances

  MAUDE report 16211781 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FULLY INSERTED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DURING A SECONDARY PROCEDURE DUE TO VISUAL DISTURBANCES. THE ISSUE WAS FIRST OBSERVED AFTER IMPLANTATION. THE PATIENT'S SYMPTOMS PERSISTED FOR 2 MONTHS. A NON-JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT. NO VITRECTOMY, SUTURE, OR INCISION ENLARGEMENT WAS REQUIRED. NO MEDICATION WAS PRESCRIBED. DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 15939981 ↗
• 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) STARTED FALLING TOWARDS THE BACK OF THE EYE AS THE CHAMBER WAS UNSTABLE. THERE WAS PATIENT CONTACT. THE PRODUCT IS BEING RETURNED FOR EVALUATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 15874882 ↗