CT LUCIA CT LUCIA 621P.AM DPT 21.5Recalls & reported problems
Carl Zeiss Meditec Production, LLC · 1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +21.5D · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843045102311), received between Jun 24, 2024 and Aug 6, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Advance” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Advance1
- Use of Device Problem1
Patient problems
- Visual Impairment2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2024Failure to Advance; Failure to Advance
IT WAS REPORTED THAT THE HAPTIC OF A CT LUCIA 621P LENS WAS STUCK AND DID NOT COME OUT OF THE INJECTOR CORRECTLY. THIS CAUSED IT TO BE INSERTED INTO THE CORNEA. THE DOCTOR REMOVED THE LENS AND USED A NEW LENS.
Patient problems: Visual Impairment
MAUDE report 19922322 ↗InjuryJun 24, 2024Use of Device Problem; Use of Device Problem
THE INJECTOR CRACKED AND THE HAPTIC BROKE. THE OPTIC WAS REMOVED SUCCESSFULLY FROM THE EYE DURING THE SAME SURGERY WITHOUT ANY PATIENT INJURIES.
Patient problems: Visual Impairment
MAUDE report 19594534 ↗
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 · TerminatedIntraocular 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 · TerminatedIntraocular 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 · TerminatedPrecision Aspheric Lens (PAL) Intraocular Lens Model: EC-3 PAL, Serial Number: 1169381106, 1169391106, 1169421106 The device is indicated for primary implantation in the capsular
Other Intraocular Lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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