CT LUCIA CT LUCIA 621P.AM DPT 19.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843045102274), received between Jul 25, 2023 and Jul 25, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2023Break; Break

  ON (B)(6), 2023 THE DOCTOR HAD A COMPLICATION WITH A 621P IOL IN WHICH THE HAPTIC BROKE DURING INSERTION OF THE IOL. IT WAS STATED BY THE CUSTOMER THAT THERE WAS NO DAMAGE NOTED TO THE DEVICE DURING PREPARATION FOR USE. UPON INSERTION OF THE LENS, THE DELIVERY DEVICE WAS ABOUT TO BE REMOVED WHEN THE VIEW OF THE HAPTIC WAS DETACHED FROM THE OPTIC. AT THIS TIME, THE DOCTOR REMOVED THE DELIVERY DEVICE AND BEGAN TO REMOVE THE HAPTIC AND LENS. THE CUSTOMER STATED THERE WAS A DELAY IN REMOVAL OF BOTH THE HAPTIC AND THE OPTIC. THE LENS WAS SUCCESSFULLY REMOVED WITH NO COMPLICATION. THE LENS WAS REPLACED WITH ANOTHER ZEISS LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391113 ↗

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