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

Model Number	003500-0050-674
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a ct lucia 602 was explanted due to the lens tilting at the haptic optic junction.Backup lens was implanted to successfully complete the procedure.No adverse patient effects or clinically significant delay in procedure reported.No additional information provided.
Additional Manufacturer Narrative
During the processing of this complaint, attempts were made to obtain complete event, patient, and device information.It was reported that a ct lucia 602 was explanted due to the lens tilting at the haptic optic junction.Backup lens was implanted to successfully complete the procedure.No adverse patient effects or clinically significant delay in procedure reported.No additional information provided.The device was not returned thus a proper device analysis could not be completed.Nor, the reported issue confirmed.There was no damage noted to the device during preparation for use reported.Thus, indicating a product quality issue did not contribute to the reported difficulties.We have reviewed the device history records and sterilization records.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.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 factor may have caused or contributed to the reported issues is but is not limited to: distorted haptic/optic tilt are known to be caused by numerous factors including, but not limited to: lens placement technique and accessory device support.We have reviewed the information provided and at this time there is no indication of a product quality issue with respect to the manufacturing, design, or labeling of the device.It appears that the reported issue is linked to user error.However, the need to explant the lens is considered need for medical intervention in order to prevent and avoid permanent impairment or damage to a body structure.

• 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: charlie ortiz ; 1040 s vintage ave. bld. a; ontario, CA 91761 ; 9099065165
• MDR Report Key: 13255852
• Report Number: 3010126268-2022-00003
• Device Sequence Number: 4593837
• Product Code: HQL
• UDI-Device Identifier: 00843045100959
• UDI-Public: (01)00843045100959(17)250731
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P100016-S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2022

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: 07/31/2025
• Device Model Number: 003500-0050-674
• Device Catalogue Number: 003500-0050-674
• Device Lot Number: 3S201380
• 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: 12/16/2021
• Initial Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2020
• 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