MAUDE Adverse Event Report: CARL ZEISS MEDITEC PRODUCTION LLC CT LUCIA 602

Model Number	602
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	03/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the doctor had a case where the lens was positioned well at the end of the case, but the next day it had rotated a full 180 degrees.There are plans to explant the lens.
Additional Manufacturer Narrative
The device is not being sent back.Thus, a proper device analysis could not be completed, nor the reported issues confirmed.Additionally, it was stated by the customer that they are using the yamane technique to implant the lenses.This technique induces a larger amount of force while trying to position the haptics in the scleral tunnel.Our lenses are intended to be implanted in the capsular bag.Thus, the lens was being used off-label.Based on the information provided, the risk assessment for the lucia product and based on our experience and other complaints that have already been resolved we have determined that the following factors may have cause or contributed to the injection issues is but is not limited to: · loading strategy · lens placement technique · accessory device support · poor handling during folding and inserting risk assessment has been reviewed within the technical file for hydrophobic lens.Risk assessment identifies decentration/ tilting of the iol inside the eye to potentially because by improper handling during surgery, imperfect surgical procedure.This is seen as a normal event that may result in additional surgery because of impaired vision.This is considered as a serious severity of damage that may result in injury or disability which requires surgical intervention.The likelihood of occurrence is estimated to be remote.The resulting risk is deemed acceptable.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 met all criteria for release.
Additional Manufacturer Narrative
Description of changes: field b5: updated to "the lens has been explanted." field g3: updated "date received by manufacturer".Field g6: updated to "follow-up # 1" and "30-day".Field h2: selected "correction, additional information, and device evaluation".Field h3: updated to "yes".Checked "evaluation summary attached" box.Field h6: added component code "4720".Added type of investigation to "10".Updated investigation conclusions to "67, 19, 18".Field h10: added description of changes.
Event or Problem Description
It was reported that the doctor had a case where the lens was positioned well at the end of the case, but the next day it had rotated a full 180 degrees.The lens has been explanted.

• Brand Name: CT LUCIA 602
• Common Device Name: CT LUCIA 602
• 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
• MDR Report Key: 16850333
• Report Number: 3010126268-2023-00061
• Device Sequence Number: 17835403
• Product Code: HQL
• UDI-Device Identifier: 00843045100966
• UDI-Public: (01)00843045100966(17)260930
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P10016-S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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: 09/30/2026
• Device Model Number: 602
• Device Catalogue Number: 003500-0050-675
• Device Lot Number: 3S211135
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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