CT LUCIA CT LUCIA 602.US/+18.5DRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00843045100904), received between Jan 8, 2021 and Jul 23, 2024 — classified as 29 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (23 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC BROKE OFF IN THE PATIENT'S EYE. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 19809786 ↗
• InjuryJul 18, 2024Use of Device Problem; Use of Device Problem

  HAPTIC WAS SEPARATED FROM OPTIC AFTER IMPLANTATION. IOL WAS EXPLANTED AND REPLACED WITH ANOTHER CT LUCIA LENS IN THE SAME PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 19778704 ↗
• InjuryFeb 1, 2024Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED A BROKEN HAPTIC. THE HAPTIC BROKE WHILE IN THE PATIENT'S EYE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 18628328 ↗
• InjuryFeb 1, 2024Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED A BROKEN HAPTIC. THE HAPTIC BROKE WHILE IN THE PATIENT'S EYE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 18628237 ↗
• InjuryJan 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE CUSTOMER REPORTED EXPLANTATION OF A CT LUCIA 602 LENS AS THE IOL HAD "DISLOCATED".

  Patient problems: Visual Impairment

  MAUDE report 18567477 ↗
• InjuryJan 23, 2024Optical Decentration; Optical Decentration

  IT WAS REPORTED THAT THE DOCTOR WAS UNABLE TO CENTER A CT LUCIA 602. THE IOL WAS REMOVED AND A NEW LENS WAS IMPLANTED SUCCESSFULLY.

  Patient problems: Visual Impairment

  MAUDE report 18567472 ↗
• InjuryJul 18, 2023Device Slipped; Use of Device Problem; Device Dislodged or Dislocated; Device Slipped; Use of Device Problem; Device Dislodged or Dislocated

  ON (B)(6) 2023, IT WAS REPORTED BY DOCTOR THAT THE CT LUCIA 602 ROTATED AFTER THE IOL WAS FIXATED USING INTRASCLERAL HAPTIC FIXATION, YAMANE TECHNIQUE. THE IOL LOOKED WELL CENTERED AND IN PLANE WITH THE IRIS AT END OF SURGERY. ON (B)(6) 2023, THE IOL HAD "SOMMERSAULTED" WITH FORWARD 90-DEGREE ROTATION SO THAT INSTEAD OF LOOKING THROUGH THE OPTIC, BOTH PATIENT AND EXAMINER WERE LOOKING AT EDGE OF OPTIC. THE PATIENT ADVERSE EFFECTS INCLUDE, POOR VISION (HAND MOTION), AND IRIS CHAFING OF THE IOL CAUSING PROLONGED INFLAMMATION AND INABILITY TO TAPER OFF STEROID DROPS. THE IOL WAS EXPLANTED ON (B)(6) 2023. THE PATIENT WAS LEFT APHAKIC DUE TO TRAVEL PLANS THIS SUMMER. THE DOCTOR WILL GO BACK IN LATER AND SUTURE A LENS TO THE SCLERA.

  Patient problems: Visual Impairment

  MAUDE report 17347344 ↗
• InjuryJun 27, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC BROKE. LENS WAS REMOVED AND ANOTHER LENS WAS IMPLANTED.

  Patient problems: Visual Impairment

  MAUDE report 17210908 ↗
• InjuryJun 6, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE LENS HAS ROTATED 180 DEGREES WHEN SEEING THE PATIENT FOR A 1-WEEK POST OP VISIT. THE DOCTOR HAD TO DO SURGERY TO REMOVE THIS LENS AND PLACE A NEW ONE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 17070284 ↗
• InjuryMay 11, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE HAPTIC ON THE LENS FLIPPED DURING A PROCEDURE. A SPARE LENS WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WAS REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 16916294 ↗
• InjuryMay 11, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE HAPTIC ON THE LENS FLIPPED DURING A PROCEDURE. A SPARE LENS WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WAS REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 16916115 ↗
• InjuryApr 26, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THE LENS HAD A BROKEN HAPTIC. THE LENS WAS PARTIALLY IMPLANTED AND THEN REMOVED DURING THE SAME PROCEDURE. A SPARE LENS WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16820292 ↗
• InjuryApr 10, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT: "THE LENS HAD VAULTED AND TURNED SIDEWAYS THE NEXT DAY AFTER THE LENS WAS IMPLANTED. THE LENS WAS EXPLANTED ON (B)(6)2023 DURING THAT TIME THE SURGEONS NOTICED THAT A HAPTIC WAS BROKEN AT THE HAPTIC LENS JUNCTION. THE LENS WAS REMOVED, AND THE PATIENT IS APAKIC. NEXT STEPS ARE FOR THE SURGEON TO WAIT A PERIOD OF TIME AND TRY AND IMPLANT ANOTHER LENS. IT WAS STATED THAT THE DOCTOR USED THE YAMANE TECHNIQUE AND STANDARD INJECTOR. NO PATIENT INJURIES WERE CONFIRMED."

  Patient problems: Visual Impairment

  MAUDE report 16710313 ↗
• InjuryMar 15, 2023Off-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, THE IOL TILTED. THE LENS WAS REMOVED AND AN ACIOL WAS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16547820 ↗
• InjuryFeb 15, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT AFTER A CT LUCIA 602 WAS IMPLANTED, THE IOL TILTED. THE LENS WAS EXPLANTED, AND ANOTHER LENS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16383476 ↗
• InjuryFeb 6, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE IOL TITLED DUE TO THE OPTIC-HAPTIC TWISTING. THE LENS WAS REMOVED, AND ANOTHER LENS WAS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16309488 ↗
• InjuryFeb 6, 2023Off-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 THE IOL TILTED DUE TO THE OPTIC-HAPTIC TWISTING. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16309416 ↗
• InjuryFeb 2, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE LENS TILTED IN THE EYE. THE LENS WAS REMOVED AND ANOTHER LENS WAS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16285360 ↗
• InjuryJan 13, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT AFTER THE DOCTOR IMPLANTED A CT LUCIA 602, HE DECIDED TO REMOVE THE LENS AND IMPLANT ANOTHER LENS. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16163054 ↗
• InjuryJan 9, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A CT LUCIA 602 WENT INTO THE EYE OF THE PATIENT AND HAD TO BE REMOVED DURING THE CASE. A SECOND CT LUCIA 602 WAS IMPLANTED. NO PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16127811 ↗
• InjuryJan 6, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT HAD AN OPEN POSTERIOR CAPSULE AND COMPLICATED CATARACT SURGERY WHERE A CT LUCIA 602 WAS IMPLANTED. HOWEVER, THE LENS TILTED INTRAOPERATIVELY AND WAS EXPLANTED. A BACKUP LENS WAS IMPLANTED AND WAS STABLE POST-OPERATIVELY. NO PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. IT WAS STATED THE DOCTOR WAS USING THE YAMANE TECHNIQUE TO IMPLANT THE LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16116305 ↗
• InjuryJan 6, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT HAD AN OPEN POSTERIOR CAPSULE AND COMPLICATED CATARACT SURGERY WHERE A CT LUCIA 602 WAS IMPLANTED. HOWEVER, THE LENS TILTED INTRAOPERATIVELY AND WAS EXPLANTED. A BACKUP LENS WAS IMPLANTED AND WAS STABLE POST-OPERATIVELY. NO PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. IT WAS STATED THE DOCTOR WAS USING THE YAMANE TECHNIQUE TO IMPLANT THE LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16113236 ↗
• InjuryDec 15, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AFTER IMPLANTING A CT LUCIA 602 IT WAS NOTED THAT THE HAPTIC WAS "STICKING OUT". THUS, THE LENS WAS REMOVED, AND A SPARE LENS WAS IMPLANTED. NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15988214 ↗
• InjuryDec 13, 2022Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THE CUSTOMER WAS USING THE CT LUCIA 602 FOR A YAMANE TECHNIQUE. FOR THE MOST PART IT SEEMED TO GO WELL UNTIL THEY STARTED CLOSING ALL OF THE INCISIONS AND THAT'S WHEN IT WAS NOTICED THAT THE IOL WAS TILTING. ONE OF THE OTHER SURGEONS ATTEMPTED TO REPOSITION THE IOL WHEN ONE OF THE HAPTICS DISLOCATED. THE IOL DISLOCATED AS HE ATTEMPTED TO ANTERIORIZE THE IOL. THE SURGERY ENDED UP TAKING AN EXTRA 2.5 HOURS BECAUSE OF THE TILTING OF THE LENS. THIS INCLUDED ATTEMPTING TO REPOSITION THE LENS AFTER IT TILTED, THE OPTIC FALLING TO THE BACK AFTER SEPARATING FROM THE HAPTICS, REPLACING PORTS AND REMOVING THE OPTIC FROM THE BACK OF THE EYE, FIXATING A NEW LENS TO THE SCLERA, AND CLOSING UP. IN THE PROCESS OF REMOVING THE DEFECTIVE IOL, IT WAS NECESSARY TO SCRAPE CORNEAL EPITHELIUM DUE TO DETERIORATION OF THE VIEW, LEADING TO A COMPLETE CORNEAL EPITHELIAL DEFECT ON POSTOPERATIVE DAY ONE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15974363 ↗
• InjuryDec 6, 2022Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC FELL OFF AT THE OPTIC HAPTIC JUNCTION. THE LENS WAS REMOVED AND A NEW ONE WAS PLACED IN THE PATIENT'S EYE. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15924060 ↗

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