MAUDE Adverse Event Report: CARL ZEISS MEDITEC PRODUCTION LLC CT LUCIA; CT LUCIA 621P

Model Number	621P
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A proper root cause analysis could not be completed nor the reported issue confirmed.Without a proper device analysis, a definitive root cause cannot be determined at this time.There was no damage reported to have been noticed during the inspection prior to use and preparation, which suggests a product deficiency did not contribute to the reported difficulties.Based on the information provided, the risk assessment for the lucia product, and our experience, we have determined that the following factors may have caused or contributed to the reported issue but not limited to: · misplacement of the lens: this may occur during ovd application where the cannula may catch the edge of the lens or haptic; thus, removing the lens off the "track" inside the cartridge.This may also cause the lens to fold improperly.The lens should fold in a "u" shape and if it does not this will cause the lens to eject improperly and could cause damage to the lens.· inadequate application of ovd: the ifu asks for generous amount of ovd to be applied, which covers the lens and the blue cushion.If ovd is not placed on the blue cushion advancement of the plunger may be inhibited by high frictional force and appear to become stuck.· dwell time after preparation: the ifu indicates that after you cover the whole lens and blue cushion with a generous amount of ophthalmic viscoelastic.Avoid touching the lens and blue cushion.You are to close the lid of the iol chamber to allow the lens to remain in this position until the surgeon is ready to implant it into the eye.Then you are to advance the lens to the intermediate position.Gently press the plunger forward until an audible "click" is heard.The ifu recommends that after the lens is advanced into the conical section, the lens must be injected immediately.Dwell scenarios where the lens sits in this position for a prolong time prior to injection may lead to stuck iol issue.Viscoelastic materials may lose their lubricity if allowed to stand too long.· excess force: this may be experienced when the blue cushion bypasses the iol.By attempting to push out the overridden iol, the volume of the injector tip increases and can cause the injector tip to crack or result in a stuck iol.If there is any resistance felt during implantation, the surgeon should stop immediately.It is recommended that devices with a higher diopter should advance the lens slowly, to allow the blue cushion to reshape and prevent the bypass of the iol.The device history records were reviewed and there were no non-conformities or deviations noted during the manufacturing of the lens that would have caused or contributed to the nature of this complaint.Additionally, our lenses are 100% inspected before they leave our manufacturing site.Therefore, we are confident that the lens was processed per standard operating procedures and inspections and have met all criteria for release.
Event or Problem Description
It was reported that the barrel of the inserter was split and lens was damaged.The damaged lens was extracted, and the backup lens was inserted without additional complications.

• Brand Name: CT LUCIA
• Common Device Name: CT LUCIA 621P
• Manufacturer (Section D): CARL ZEISS MEDITEC PRODUCTION LLC; 1040 s. vintage ave. bld. a; ontario CA 91761
• Manufacturer (Section G): CARL ZEISS MEDITEC PRODUCTION LLC; 1040 s. vintage ave. bld. a; ontario CA 91761
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin 94568 ; 9252164697
• MDR Report Key: 18862600
• Report Number: 3010126268-2024-00031
• Device Sequence Number: 19659906
• Product Code: HQL
• UDI-Device Identifier: 00843045102205
• UDI-Public: (01)00843045102205(11)230519(17)260430(243)1
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P10016-S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: 621P
• Device Catalogue Number: 003500-0056-474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown