CT LUCIA CT LUCIA 621P.AM DPT 22.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843045102335), received between Jun 30, 2025 and Aug 28, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (P100016); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Use of Device Problem; Patient-Device Incompatibility; Use of Device Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF THE CT LUCIA 621P IOL (INTRAOCULAR LENS), THE PATIENT WAS REFERRED TO A RETINA SPECIALIST DUE TO ZONULAR INSTABILITY. IT WAS FURTHER REPORTED THAT THE LENS MUST BE REMOVED BECAUSE THE COMPROMISED CAPSULAR BAG WAS UNSTABLE AND COULD NOT SUPPORT ANY ONE-PIECE LENS (CT LUCIA 621P), WHICH IS UNRELATED TO THE DEVICE ITSELF. THE SECONDARY SURGERY WILL INVOLVE A LENS EXCHANGE BY A RETINA DOCTOR, WHO WILL SUTURE A THREE-PIECE IOL IN PLACE. NO RETINAL PATHOLOGIES HAVE BEEN IDENTIFIED, AND THE PATIENT IS NOW UNDER THE CARE OF ANOTHER PHYSICIAN FOR THIS PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 22912528 ↗
• InjuryAug 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SPOT WAS OBSERVED ON THE CT LUCIA 621P INTRAOCULAR LENS (IOL) AFTER IT WAS IMPLANTED INTO THE EYE. THE SURGEON EXPLANTED THE LENS AND SUCCESSFULLY IMPLANTED A NEW LENS DURING THE SAME SURGERY.

  Patient problems: Visual Impairment

  MAUDE report 22734396 ↗
• InjuryJun 30, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CT LUCIA 621P LENS WAS EXPLANTED DUE TO CAPSULAR BAG INSTABILITY. ANOTHER ZEISS LENS WAS IMPLANTED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED 15-20 MINUTES WHILE EXTRACTING AND REPLACING THE LENS. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 22358311 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100016. One submission often covers many models, so check the product and lot details in each record.

• Z-1309-2015 · Feb 13, 2015 · Terminated
  Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the
• Z-1077-2012 · Aug 2, 2011 · Terminated
  Precision Aspheric Lens (PAL) Intraocular Lens Model: EC-3 PAL, Serial Number: 1169381106, 1169391106, 1169421106 The device is indicated for primary implantation in the capsular
• Z-1076-2012 · Aug 2, 2011 · Terminated
  Intraocular Lens (IOL). Model: EC-3, Serial Number: 1169371106, 1169401106, 1169471106 The device is indicated for primary implantation in the capsular bag of the eye for the visu