TECNIS IOL ZCT600 (REF ZCT600U210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474604186), received between Jul 21, 2017 and Jun 8, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2022Contamination; Contamination

  IT WAS REPORTED THAT THE TECNIS TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE WHEN THE SURGEON OBSERVED A FILM ADHERED TO THE LENS. THE SURGEON WAS ABLE TO REMOVE THE FOREIGN MATERIAL. IT IS UNCERTAIN IF THE FILM CAME FROM THE LENS ITSELF OR IF IT WAS IN THE CARTRIDGE. THE LENS REMAINS IMPLANTED. PATIENT IS OK. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14636139 ↗
• MalfunctionDec 6, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ZCT600 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE AT 006 DEGREES AND WAS MEASURED AT THE 1-MONTH POST-OP VISIT AT 180 DEGREES. THERE WAS NO PATIENT INJURY AND THE IOL REMAINS IMPLANTED. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH THE PATIENT'S ACTIVITIES OF DAILY LIFE AND THERE IS CURRENTLY NO PLAN TO REPOSITION THE IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8136688 ↗
• MalfunctionSep 21, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT600 21.0 DIOPTER LENS ROTATED 20 DEGREES POST-OPERATIVELY. THE INITIAL IMPLANT DATE WAS (B)(6) 2018 AND THERE WAS NO PATIENT INJURY. REPORTEDLY, THE PATIENT IS FRUSTRATED AND WEARING GLASSES, AS A SECONDARY PROCEDURE TO ROTATE THE LENS WAS NOT PERFORMED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7900199 ↗
• InjuryNov 16, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT600 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. POST-OPERATIVELY, AT THE 1 MONTH VISIT, THE IOL HAD ROTATED FROM ITS INITIAL PLACEMENT OF 70 DEGREES TO 83 DEGREES. ALSO, THE UNCORRECTED VISUAL ACUITY WAS 20/70 AND THE BEST CORRECTED VISUAL ACUITY WAS 20/30. PATIENT ALSO COMPLAINED OF BLURRY VISION. REPORTEDLY, THERE WAS NO INTERFERENCE WITH ACTIVITIES OF DAILY LIFE. THERE IS CURRENTLY NO PLAN TO REPOSITION THE LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 7038583 ↗
• InjuryJul 21, 2017Incorrect Measurement; Unintended Movement; Incorrect Measurement; Unintended Movement

  IT WAS REPORTED THAT A ZCT600 21.0 DIOPTER INTRAOCULAR LENS (IOL) ROTATED AND THERE WAS A MISS CALCULATION WITH THE PCA FUNCTION. THE LENS WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL LENS WITH THE SAME DIOPTER SIZE. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6733767 ↗