TECNIS IOL ZCU150 (REF ZCU150U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474657809), received between Nov 17, 2020 and Aug 6, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT REPORTED A PLANNED EXPLANT OF A TORIC INTRAOCULAR LENS (IOL) DUE TO REFRACTIVE SURPRISE (MYOPIC SHIFT) DESPITE USING OPTIWAVE REFRACTIVE ANALYSIS (ORA) AT ORIGINAL SURGERY. THE PATIENT ALSO EXPERIENCED DIPLOPIA FOR TWO (2) MONTHS AND SHADOWING. IT WAS CONFIRMED THAT THE PATIENT IS NOT DEBILITATED. IT WAS INDICATED THAT THE ISSUE WAS NOT DUE TO CALCULATION ERROR. THE ORIGINAL LENS WAS WITH A RESIDUAL PRESCRIPTION (RX) -1.00 -0.50 X138. TARGET WAS PLANO (0.00). PATIENT WAS REPORTED STATUS POST (S/P) MYOPIC LASIK IN BOTH EYE (OU). BIOMETRY AND TOPOGRAPHY WERE NOT OBTAINED POST-OP. NO PATIENT INJURY WAS REPORTED. THROUGH FOLLOW UPS, IT WAS LEARNED THAT THE LENS WAS EXPLANTED ON (B)(6) 2024. ANOTHER JOHNSON & JOHNSON LENS OF THE SAME MODEL, BUT OF A LOWER DIOPTER (19.5 D) WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE AS A REPLACEMENT IOL. NO OTHER MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT IS DOING WELL, SEEING 20/25 WITH POST OPERATIVE EXPECTED FINDINGS AT 1-DAY POST OP. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR REPORT PERTAINS TO PATIENT'S RIGHT EYE (OD). NO COMPLAINT WITH THE PATIENT'S LEFT EYE (OS) REPORTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 19925071 ↗
• MalfunctionMay 15, 2023Break; Break

  IT WAS REPORTED THE ZCU150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). PATIENT STATED FOR THE PAST TWO YEARS SHE HAS BEEN HAVING ISSUES WITH HER SIGHT. IOL IS CAUSING HER BLINDNESS IN ANY KIND OF LIGHT AND SEVERE GLARE. ON (B)(6) 2023, SHE SAW HER 5TH DOCTOR, AND WAS INFORMED THAT, THE IOL THAT WAS PLACED IN HER RIGHT EYE, HAS ROUGH EDGES. PATIENT REACHED OUT TO REQUEST A REFUND, SHE WAS INFORMED THAT ANY CREDITS WOULD BE ISSUED TO THE FACILITY WHO PURCHASED THE IOL. SHE INDICATED SHE WILL REACH OUT TO THE SURGEON WHO PLACED THE IOL. PATIENT WAS PROVIDED WITH COMPLAINT FOLDER INFORMATION, (B)(4), TO PROVIDE TO THE SURGEON. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING DOCTOR HAS CONFIRMED BLINDNESS IN ANY KIND OF LIGHT. DOCTOR ALSO HAS A PHOTO OF ROUGH EDGES OF THE LENS. PATIENT STATED ORIGINAL IOL IMPLANT DOCTOR IS NO LONGER HER DOCTOR AND PROVIDED ORIGINAL DOCTOR CONTACT INFORMATION TO OBTAIN VISUAL ACUITY MEASUREMENTS. ORIGINAL IOL IMPLANT DOCTOR STATED HE HAS TRIED TO CALL THE PATIENT MULTIPLE TIMES TO COME IN FOR AN EVALUATION AND SHE HAS NOT RETURNED HIS CALLS. HE RECENTLY SENT HER A LETTER REQUESTING HER TO COME I

  Patient problems: Visual Disturbances

  MAUDE report 16934328 ↗
• InjuryOct 13, 2022Adverse 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 IMPLANTED, THE PATIENT WAS DOING WELL, BUT EXPERIENCING SOME MILD TO MODERATE CORNEAL EDEMA AT THE WOUND. THE PATIENT'S UNCORRECTED VISION IS 20/40 POST OPERATIVE DAY 2. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE CORNEA EDEMA WAS FIRST NOTED ON THE FIRST POST-OPERATIVE DAY, (B)(6) 2022. THE SURGEON ADDED PREDNISOLONE ACETATE 1% QID, TAPERING BY ONE DROP EACH WEEK TO THE PRED/MOXI/BROM USED THAT WAS USED (WITH THE SAME INSTRUCTIONS) IN ORDER TO SPEED THE RESOLUTION OF CORNEAL EDEMA. THE PATIENT IS FINISHED WITH THOSE DROPS NOW. THE PATIENT NO LONGER HAS CORNEAL EDEMA BUT STILL HAS TRACE DESCEMET'S FOLDS AT THE WOUND. THE PATIENT'S BEST CORRECTED VISION IS 20/25 WITH -0.25 +0.50 X 90. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; Eye Injury

  MAUDE report 15601892 ↗
• InjuryJan 7, 2022Adverse 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 OPERATIVE EYE AS OTHER DISORDERS WERE FOUND DURING THE POST-OPERATIVE EXAMINATION. A SAME LENS MODEL WITH DIFFERENT DIOPTER (17.5D) WAS USED AS THE REPLACEMENT IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Eye Injury

  MAUDE report 13196645 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WERE 6 CASES OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS). IT WAS LEARNED THAT FOR THIS EVENT, THE VISUAL SYMPTOMS OF BLURRY DEBILITATING, FOUND TO HAVE PUNCTATE KERATITIS AND MILD EDEMA DIFFUSELY. FURTHER FOLLOW-UP CONFIRMED THAT PATIENT SYMPTOMS WAS TASS. TREATMENT PROVIDED WAS INTENSIVE TOPICAL STEROIDS. THE FOLLOWING MEDS WERE ALSO GIVEN BUT WAS NOTED AS THE DOCTOR'S STANDARD CARE, PROLENSA EVERYDAY, INVELTYS 2X/DAY, MOXIFLOXICAN 2X/DAY, ARTIFICIAL TEARS, EVERY 1 HOUR. IT WAS STATED THAT CURRENT PATIENT STATUS IS THAT PATIENT DOING WELL, RESOLVED KERATITIS AND EDEMA, BEST CORRECTED VISUAL ACUITY (BCVA) 20/20. INTRAOCULAR LENS (IOL) REMAINS IMPLANTED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE OTHER PRODUCTS ARE NOT BEING RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE CUSTOMER INVESTIGATED THE CASES. HOWEVER, ROOT CAUSE FOR THE TASS HAS NOT BEEN DETERMINED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS 5 OF 6 CASES FOR TASS CAPTURING THE EVENT FOR THE INTRAOCULAR LENS (IOL). SEPARATE REPORTS ARE BEING SUBMITTED FOR EACH OF THE OTHER PRODUCTS INVOLVED.

  Patient problems: Blurred Vision; Keratitis; Swelling/ Edema; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 12200466 ↗
• MalfunctionJan 13, 2021Unstable; Unstable

  THE CUSTOMER REPORTED THAT AN INTRAOCULAR LENS ROTATED. THE LENS REMAINS IMPLANTED. PRE-OP: 20/25-1, DSC 20/40-2. PATIENT OUTCOME: 1 WEEK: 20/25, DSC 20/25-2; 1 MONTH 20/25, DSC 20/25+2; 2 MONTHS 20/25, DSC 20/30. ADDITIONALLY IT WAS REPORTED THAT LENS AXIS WAS 175 DEGREE ON (B)(6) 2020 DAY OF SURGERY AND LENS AXIS WAS 147 ON (B)(6) 2020. THE LENS ROTATION ISSUE FIRST NOTED ON (B)(6) 2020, 1 WEEK POST OPERATION. THE DOCTOR IS MONITORING THE LENS AND DISCUSSED THE ISSUE AS WELL AS THE OPTIONS WITH THE PATIENT ON (B)(6) 2020. NO VISUAL ISSUES OR SYMPTOMS AS A RESULT OF THE LENS ROTATION WERE REPORTED. AS OF TO DATE, NO LENS REPOSITIONING HAS BEEN PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167414 ↗
• InjuryNov 17, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE SURGEON IMPLANTED THE INTRAOCULAR LENS (IOL) AT A WRONG ANGLE. THE SURGEON WENT TO ROTATE THE LENS, BUT WAS ONLY ABLE TO ROTATE THE LENS HALF WAY TO WHERE HE WANTED IT TO BE. ONCE THE EYE CALMS DOWN, THE SURGEON IS HAVING THE PATIENT COME BACK FOR PHOTOREFRACTIVE KERATECTOMY (PRK). THROUGH FOLLOW-UP, IT WAS LEARNED THEY WERE NOT ABLE TO ROTATE THE LENS BACK INTO POSITION. THE LENS REMAINS IMPLANTED. A PRK ENHANCEMENT IS SCHEDULED FOR (B)(6) 2020. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10857208 ↗