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

Model Number	003500-0050-670
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon didn't like how the lens was sitting in the eye.The lens was removed.No patient injury.Spare lens was used to successfully complete.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 the surgeon didn't like how the lens was sitting in the eye.The lens was removed.No patient injury.Spare lens was used to successfully complete.No adverse patient effects or clinically significant delay in procedure reported.No additional information provided.The device history records were reviewed and there were no non-conformities or deviations noted during the manufacturing of the lenses that would have contributed to the nature of this complaint.Additionally, lenses are 100 % inspected before they leave our manufacturing site.Therefore, we are confident that the lens was processed per standard operation procedures and inspections and met all of the criteria for release.Additionally, there was no damage noted to the lens during preparation for use which suggest a product deficiency did not contribute to the reported issue.Failed injections are known to be caused by numerous factors including, but not limited to: loading strategy, lens placement technique, poor handling during folding and inserting, patient pathology.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 off label use.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: 13826031
• Report Number: 3010126268-2022-00008
• Device Sequence Number: 16393792
• Product Code: HQL
• UDI-Device Identifier: 00843045100911
• UDI-Public: (01)00843045100911(17)260228
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2022

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: 02/28/2026
• Device Model Number: 003500-0050-670
• Device Catalogue Number: 003500-0050-670
• Device Lot Number: 3S210215
• 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: 03/01/2022
• Initial Report FDA Received Date: 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2021
• 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