CT LUCIA CT LUCIA 602.US/+16.0DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843045100850), received between May 2, 2023 and Apr 29, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  CUSTOMER REPORTED THAT A LENS WAS IMPLANTED ON (B)(6) 2024, BUT IT WAS EXPLANTED IMMEDIATELY DUE TO LENS PLACEMENT ISSUES ON THEIR END. ANOTHER LENS WAS IMPLANTED SUCCESSFULLY. THE YAMANE TECHNIQUE WAS USED.

  Patient problems: Visual Impairment

  MAUDE report 19209495 ↗
• InjuryMay 2, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  CUSTOMER REPORTED A ROTISSERIE TILT CASE. THE PATIENT HAS DECREASED VISION DUE TO THE DISLOCATED LENS, AND SHE WILL REQUIRE ADDITIONAL SURGERY FOR LENS EXCHANGE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16856981 ↗

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