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

Model Number	003500-0050-673
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the processing of this complaint, attempts were made to obtain complete event, patient, and device information.The lens has been discarded thus, a proper device analysis could not be completed.Additionally, it was stated by the customer that no damage was noted to the lens during preparation for use.It was also mentioned by the customer that they are using an emerald series injector and cartridge to implant lenses.Ct lucia 602 is meant to be injected using zeiss r28 injector system and z cartridges.Based on the information provided the iol was used with another injector; thus, we are led to believe that the iol was loaded incorrectly resulting in the iol becoming scratched during injection.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.Scracthed optic issues 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 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.
Event or Problem Description
It was reported that after the implantation of a ct lucia 602 it was noted that the lens had a scratch on it.The lens was explanted and another lens was implanted to successfully complete the procedure.No adverse patient effects or clinically significant delay in procedure reported.No additional information provided.

• 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
• MDR Report Key: 12327939
• Report Number: 3010126268-2021-00001
• Device Sequence Number: 14155049
• Product Code: HQL
• UDI-Device Identifier: 00843045100942
• UDI-Public: (01)00843045100942(17)250831
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P100016
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2021

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: 08/31/2025
• Device Model Number: 003500-0050-673
• Device Catalogue Number: 003500-0050-673
• Device Lot Number: 3S201300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention