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

Model Number	003500-0050-671
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a ct lucia was being implanted using the intrascleral haptic fixation.During the case while the second haptic was being externalized the first haptic dislodged from it's scleral fixated position.After attempts to fixate the haptics the optic of the iol was continually decentered.The ct lucia iol was removed from the eye and there was no injury to the patient.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 being implanted using the intrascleral haptic fixation.During the case while the second haptic was being externalized the first haptic dislodged from its scleral fixated position.After attempts to fixate the haptics the haptics were damaged.The iol was removed from the eye and spare lens was used to successfully complete the procedure.There was no injury to the patient or clinically significant delay in procedure.No additional information provided.It was stated by the customer that they are using the yamane technique to implant 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; therefore, the lenses are being used off-label.The device was not returned, thus a proper device analysis could not be completed nor the reported issue confirmed.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.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 cause or contributed to the issue 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: 14379848
• Report Number: 3010126268-2022-00010
• Device Sequence Number: 6714837
• Product Code: HQL
• UDI-Device Identifier: 00843045101000
• UDI-Public: (01)00843045101000(17)260131
• 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
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/12/2022

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: 10/31/2025
• Device Model Number: 003500-0050-671
• Device Catalogue Number: 003500-0050-671
• Device Lot Number: 3S201542
• 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: 04/25/2022
• Initial Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2020
• 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