CT LUCIA CT LUCIA 602.US/+14.0DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843045100812), received between Mar 21, 2024 and Mar 31, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Off-Label Use” (3 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.

• InjuryMar 31, 2025Optical Decentration; Off-Label Use; Use of Device Problem; Optical Decentration; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT A CT LUCIA 602 LENS WAS IMPLANTED WITH AN EMERALD INJECTOR AND FIXATED TO THE SCLERA USING THE YAMANE TECHNIQUE. THE LENS WAS NOT CENTERED SO THE SURGEON REPLACED IT WITH A NEW LENS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 21731858 ↗
• InjuryMar 21, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  SCLERAL FIXATION WAS ATTEMPTED WITH A 3-PIECE INTRAOCULAR LENS. EACH HAPTIC WAS REPASSED, HOWEVER, GOOD CENTRATION COULD NOT BE ACHIEVED. DUE TO PROLONGED SURGERY TIME AND UNSTABLE IRIS, DECISION WAS MADE TO EXPLANT THE IOL AND LEAVE THE PATIENT APHAKIC. YAMANE TECHNIQUE WAS USED.

  Patient problems: Visual Impairment

  MAUDE report 18949088 ↗
• InjuryMar 21, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  SCLERAL FIXATION WAS ATTEMPTED WITH A 3-PIECE INTRAOCULAR LENS. EACH HAPTIC WAS REPASSED, HOWEVER, GOOD CENTRATION COULD NOT BE ACHIEVED. DUE TO PROLONGED SURGERY TIME AND UNSTABLE IRIS, DECISION WAS MADE TO EXPLANT THE IOL AND LEAVE THE PATIENT APHAKIC. YAMANE TECHNIQUE WAS USED.

  Patient problems: Visual Impairment

  MAUDE report 18948941 ↗

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