TECNIS IOL ZCU150 (REF ZCU150U195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474657786), received between Nov 4, 2020 and Sep 22, 2021 — classified as 3 injuries, 1 malfunction.

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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2021Break; Break

  IT WAS REPORTED THAT A DEFECT IN THE OPTIC OF THE LENS WAS NOTED ONCE THE LENS WAS INSERTED IN THE PATIENT¿S EYE. A LARGER INCISION WAS MADE TO CUT AND REMOVE THE DAMAGE LENS. THEN A BACK UP LENS WAS USED AND INCISION WAS CLOSED WITH SUTURE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12511112 ↗
• MalfunctionFeb 5, 2021Unstable; Unstable

  IT WAS REPORTED THAT A CLINICAL STUDY PATIENT WAS IMPLANTED AN INTRAOCULAR LENS (IOL). IOL WAS IMPLANTED AT 61 DEGREES ON OP DAY. AT DAY 1, IT WAS NOTED THAT THE IOL WAS 058 DEGREES. AT WEEK 1, IOL WAS NOTED TO BE AT 047 DEGREES. IT WAS STATED THAT THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH THE PATIENT¿S DAILY LIFE. NEVERTHELESS, ADDITIONAL INFORMATION WAS RECEIVED THAT AT 1-WEEK POSTOPERATIVE IOL AXIS WAS ESTIMATED TO BE RIGHT EYE (OD) AT 047 DEGREES. THE UNCORRECTED VISUAL ACUITY OD AT THE 1-WEEK POSTOPERATIVE (PO) VISIT: 20/25. MANIFEST REFRACTION OD: +0.75 -0.50 X 042. BEST-CORRECTED VISUAL ACUITY OD: 20/25. SUBJECT REPORTED NO VISUAL SYMPTOM COMPLAINTS THIS VISIT. THERE WAS NO SURGICAL INTERVENTION PLANNED AT THIS TIME. IT WAS LEARNED IN FURTHER FOLLOW-UP THAT THE COMPLAINT WAS BASED UPON A SUBJECTIVE ESTIMATE MADE BY THE INVESTIGATOR FROM A SLIT-LAMP MEASUREMENT. FOR THIS STUDY, CLINICAL HAS ALSO BEEN DOING INDEPENDENT ANALYSIS OF THE IOL PHOTOS TAKEN AT EACH VISIT. THESE ARE OBJECTIVE MEASUREMENTS OF THE ACTUAL IOL AXIS. BASED ON THIS OBJECTIVE MEASUREMENT, THE ACTUAL AMOUNT OF IOL ROTATION FOR THE SUBJECT BELOW IS LESS THAN 03 DEGREES. THERE IS STILL NO SURGICAL INTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11290038 ↗
• InjuryNov 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THERE WAS PATIENT CONTACT WITH THE INTRAOCULAR LENS (IOL), AND THERE WAS CAPSULE TEAR. THE IOL COULD NOT BE POSITIONED WELL AFTER TRYING TO IMPLANT. SUSPECT LENS THEN WAS REPLACED WITH A DIFFERENT LENS MODEL, ZA9003. A VITRECTOMY WAS PERFORMED, HOWEVER, THERE WAS NO INCISION ENLARGEMENT, OR SUTURES REQUIRED. NO REPORTED PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 10858101 ↗
• InjuryNov 4, 2020Smoking; Smoking

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT RIGHT EYE DUE TO BLURRY VISION POST CATARACT AS THE POWER OF THE IOL WAS INCORRECT FROM WHAT WAS RECORDED. THE OPTICAL RESPONSE ANALYZER (ORA) MACHINE WAS USED DURING SURGERY, SO THE CONTACT STATED THEY ASSUME THAT IT WAS A POWER CALCULATION ISSUE THAT OCCURRED DURING SURGERY. LENS WAS REPLACED ANOTHER LENS OF THE SAME MODEL, BUT LOWER DIOPTER, 18.5. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10783025 ↗