CT LUCIA CT LUCIA 602.US/+15.0DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00843045100836), received between Mar 15, 2024 and Dec 1, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF A CT LUCIA 602 LENS, A CREASE DOWN THE CENTER WAS OBSERVED. THE LENS WAS EXPLANTED AND DISPOSED. ANOTHER LENS WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE DOING FINE.

  Patient problems: Visual Impairment

  MAUDE report 23688944 ↗
• InjuryAug 14, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  DURING AN INTRAOCULAR LENS (IOL) EXCHANGE, THE DOCTOR REMOVED AN OLD LENS (ALCON) AND USED THE YAMANE TECHNIQUE TO IMPLANT A CT LUCIA 602 LENS. HOWEVER, THE HAPTIC WAS DAMAGED DURING STABILIZATION USING A LASER, RENDERING THE CT LUCIA 602 LENS UNUSABLE. THE CT LUCIA 602 LENS WAS EXPLANTED DURING THE SAME PROCEDURE. ANOTHER ZEISS LENS WAS SUCCESSFULLY IMPLANTED.

  Patient problems: Visual Impairment

  MAUDE report 22811459 ↗
• InjuryFeb 12, 2025Use of Device Problem; Use of Device Problem

  DURING THE LENS IMPLANTATION, THE LENS HAD DIFFICULTY ADVANCING DURING DELIVERY. POST-IMPLANTATION, THE SURGEON NOTED THAT THE HAPTICS WERE SLIGHTLY BENT. THE LENS WAS INSERTED USING A BLUE MONARCH INJECTOR WITH A B CARTRIDGE, WHICH IS AN OFF-LABEL USE. DESPITE ADEQUATE LUBRICATION, INCREASED FRICTION AND RESISTANCE REQUIRED EXCESSIVE FORCE TO ADVANCE THE LENS, LIKELY LEADING TO MECHANICAL STRESS AND BENDING OF THE HAPTICS. THE LENS WAS LATER EXPLANTED, AND NO PATIENT INJURY OR SURGICAL DELAY OCCURRED.

  Patient problems: Visual Impairment

  MAUDE report 21364108 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PLACED A CT LUCIA LENS IN A PATIENT YESTERDAY. DUE TO THE POSTERIOR EYE CONDITION, THEY NEEDED TO REMOVE THE LENS. THE LENS OR PLACEMENT OF THE LENS DID NOT CAUSE THE RETINAL DETACHMENT. THEY HAD THIS CONDITION PRIOR TO SURGERY. SURGEON FELT THAT THEY NEED FURTHER HEALING BEFORE THE LENS IS PLACED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 18911485 ↗

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