CT LUCIA CT LUCIA 621P.AM DPT 22.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843045102328), received between May 8, 2025 and Feb 19, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Device Handling Problem

  IT WAS REPORTED THAT HALF OF THE CT LUCIA 621P INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S EYE AND THE OTHER HALF (HAPTIC) REMAINED STUCK IN THE INJECTOR. THE IOL WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S EYE. THE SURGEON HAD A REPLACEMENT LENS AVAILABLE TO COMPLETE THE SURGERY. THE PATIENT WAS REPORTED TO BE FINE.

  Patient problems: Visual Impairment

  MAUDE report 24393029 ↗
• InjuryMay 8, 2025Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A CT LUCIA 621P THE HAPTIC BROKE INSIDE THE PATIENT'S EYE. THE LENS WAS CUT OUT AND REPLACED. THERE WAS NO FURTHER COMPLICATION. PATIENT RECEIVED NEW LENS AND NO INJURY IS REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 21990705 ↗

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-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
• 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