TECNIS IOL ZCU150 (REF ZCU150U230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474657854), received between Jan 13, 2021 and Jun 30, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE. DURING A POST-OPERATIVE EXAMINATION THE PATIENT COMPLAINED OF BLURRY VISION IN THE DISTANCE AND THE IOL WAS SUBSEQUENTLY EXPLANTED. THE PATIENT¿S BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OPERATIVE IS 20/25 AND BSCVA POST-OPERATIVE IS 20/20. REPORTEDLY, THE DIRECTIONS FOR USE WERE FOLLOWED. THERE WERE NO COMPLICATIONS SUCH AS SUTURES OR VITRECTOMY. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 25670488 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT CATARACT SURGERY WITH IMPLANTATION OF A SINGLE-PIECE, NON-PRELOADED TORIC INTRAOCULAR LENS (IOL) IN THE LEFT EYE. AT THE 1-WEEK POSTOPERATIVE FOLLOW-UP VISIT, THE PATIENT REPORTED INCREASED BLURRED VISION AND EXPRESSED INTEREST IN UNDERGOING AN IOL EXCHANGE PROCEDURE. NO PATIENT OR USER HARM WAS REPORTED. ADDITIONAL INFORMATION RECEIVED WITH PRODUCT RETURN CONFIRMED THAT AN EXPLANT PROCEDURE WAS PERFORMED. THE ORIGINALLY IMPLANTED LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL (MODEL RXLAL6005, 21.0 D). THE REPORTED REASON FOR THE IOL EXCHANGE WAS A POSTOPERATIVE REFRACTIVE OUTCOME MORE MYOPIC THAN THE INTENDED PLANO TARGET. PREOPERATIVE REFRACTION WAS DOCUMENTED AS +0.25 +0.75 X 180 WITH A BEST SPECTACLE-CORRECTED VISUAL ACUITY (BSCVA) OF 20/40. POSTOPERATIVE REFRACTION PRIOR TO THE EXCHANGE WAS -1.25 +0.50 X 092 WITH A BSCVA OF 20/30+2, INDICATING A MYOPIC OUTCOME RELATIVE TO THE PLANNED TARGET. THE PATIENT DID NOT EXPERIENCE A LOSS OF TWO OR MORE LINES OF BSCVA AND REPORTED NO LIMITATIONS IN ACTIVITIES OF DAILY LIVING. THERE WERE NO INTRAOPERATIVE OR POSTOPERATIVE SURGICAL COMPLICA

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 25436638 ↗
• MalfunctionMay 27, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS INITIALLY REPORTED THAT THE SURGEON NOTICED AN INTRAOCULAR LENS (IOL) HAD A PLASTIC FIBER STUCK ON THE LENS BEFORE INSERTION. THE PATIENT IS FINE AND ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL) WAS IMPLANTED AS A REPLACEMENT. THROUGH FOLLOW-UP, IT WAS LEARNED THERE WAS PATIENT CONTACT, AND ONCE THE LENS WAS IMPLANTED, THERE WAS A VISIBLE CLEAR PLASTIC ON THE LENS. IT APPEARED TO BE SIMILAR TO A PIECE OF THE CARTRIDGE. THE PLASTIC FIBER PIECE WAS REMOVED IMMEDIATELY. THE LENS REMAINS IMPLANTED. THERE WAS NO REPORT OF ANY MEDICAL/SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11897928 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCU150 MODEL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE AS PATIENT HAD DYSPHOTOPSIA. THERE WAS NO SUTURES AND VITRECTOMY BUT CUSTOMER DOES NOT KNOW IF THERE WAS INCISION ENLARGEMENT. PATIENT IS FULLY RECOVERED AND DOING FINE. ADDITIONAL DETAILS RECEIVED FROM FOLLOW UP STATES THAT THERE WAS NO ISSUE SUSPECTED WITH THE LENS AND NO PRESCRIPTION WAS GIVEN TO THE PATIENT OUTSIDE OF THE NORMAL POST-OPERATIVE TREATMENT. THE REPLACEMENT LENS USED IS A SAME MODEL BUT DIFFERENT DIOPTER LENS. SUSPECT PRODUCT WAS NOT SAVED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 11398180 ↗
• MalfunctionJan 14, 2021Unstable; Unstable

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) IMPLANTED IN THE LEFT EYE (OS) ROTATED. VISUAL ACUITY (VA): 20/70 OS, BEST CORRECTED VISUAL ACUITY (BCVA): 20/25 OS. PATIENT WOULD LIKE TO PROCEED WITH IOL ROTATION OS. MAY NEED TO HAVE MALYUGIN RING FOR GOOD DILATION. TORIC IOL ROTATION FROM 93 TO ABOUT 25-30 DEGREE (POOR DILATION SO ESTIMATED AXIS). REPOSITION OCCURRED, VITRECTOMY AND SUTURES PERFORMED. NO OTHER INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 11168696 ↗
• InjuryJan 13, 2021Adverse 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 LEFT EYE OF A PATIENT DUE TO A RESIDUAL REFRACTIVE ERROR, RESIDUAL MYOPIA AND BLURRED VISUAL ACUITY. THE ISSUES WERE OBSERVED DURING A POST-OPERATIVE EXAMINATION. A REPLACEMENT LENS OF THE SAME MODEL WITH DIFFERENT DIOPTER (22.5) WAS USED. THERE WAS NO DELAY IN PROCEDURE. THERE WAS NO SURGICAL INTERVENTION SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE PATIENT OUTCOME WAS REPORTED TO BE GOOD, 20/20. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. PRE-OPERATIVE ACUITY: 20/50. POST-OPERATIVE ACUITY: 20/25-1.

  Patient problems: Blurred Vision; Therapeutic Effects, Unexpected; Visual Impairment

  MAUDE report 11160454 ↗