MAUDE Adverse Event Report: CARL ZEISS MEDITEC PRODUCTION LLC CT LUCIA 602; CT LUCIA 602, PRODUCT CODE: HQL, PRODUCT CODE: HQL

Model Number	CT LUCIA 602
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	12/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The device has not been received yet.Thus, a proper device analysis could not be completed nor the reported issues confirmed.Our lenses are manufactured by lathing and milling a hydrophobic blank into the shape and dioptric power of the lens.The reported issue is likely caused by lathing lines.Lathing lines are a cosmetic issue that are commonly seen when the posterior and anterior surface of the lens is cut.Subsequent processes are executed to polish and remove the lens.Within these processes, our lenses are inspected for cosmetic defects and measured for optical performance.Any lens showing cosmetic defects under 10x magnification, or that does not perform to the required optical resolution are destroyed.We do know that our visual inspection is operator dependent thereby making it possible for borderline rejects to be accepted.
Event or Problem Description
It was reported that the patient describes looking through binoculars with dark crescents inside and inferior vision.Lens was removed.No additional information provided.

• Brand Name: CT LUCIA 602
• Common Device Name: CT LUCIA 602, PRODUCT CODE: HQL, PRODUCT CODE: HQL
• 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, CA 94568 ; 9252164697
• MDR Report Key: 16163146
• Report Number: 3010126268-2023-00012
• Device Sequence Number: 7508096
• Product Code: HQL
• UDI-Device Identifier: 00843045100935
• UDI-Public: (01)00843045100935(17)260831
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P100016-S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 01/13/2023

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: 08/31/2026
• Device Model Number: CT LUCIA 602
• Device Catalogue Number: 003500-0050-672
• Device Lot Number: 3S211041
• 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: 12/22/2022
• Initial Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• 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