CT LUCIA CT LUCIA 621P.AM DPT 24.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843045102373), received between Apr 17, 2024 and Jun 11, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Positioning 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.

• InjuryJun 11, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AN IOL CT LUCIA 621P WAS IMPLANTED AND THEN REMOVED FROM THE PATIENT'S EYE. THE INITIAL LENS WAS EXPLANTED WHEN IT WAS NOTED THAT THE LEAD HAPTIC WAS AMPUTATED IMMEDIATELY AFTER IMPLANTATION. A SECOND CT LUCIA 621P LENS WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 19515621 ↗
• InjuryApr 17, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE LENS WAS NOT DEPLOYING CORRECTLY, WHICH WAS IN THE OPPOSITE DIRECTION THAN NORMAL. THE LENS WAS INJECTED INTO THE EYE PARTIALLY AND THEN HAD TO BE REMOVED.

  Patient problems: Visual Impairment

  MAUDE report 19129854 ↗
• InjuryApr 17, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE LENS WAS NOT DEPLOYING CORRECTLY, WHICH WAS IN THE OPPOSITE DIRECTION THAN NORMAL. THE LENS WAS INJECTED INTO THE EYE PARTIALLY AND THEN HAD TO BE REMOVED.

  Patient problems: Visual Impairment

  MAUDE report 19129694 ↗

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