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

Model Number	003500-0050-668
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	12/15/2021
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.It was reported that when loading the lens, the haptics were noted to easily kink to the point where the lens had to be removed from the eye.Two additional lenses were attempted to be implanted; however, also experienced the same issue and resulted in the iol tilting.Thus, the lenses had to be removed from the eye.A fourth lens was implanted within the same procedure 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.It was mentioned by the customer that there was no damage noted to the device during preparation for use.Thus, indicating a product quality issue did not contribute to the reported difficulties.Additionally, it was stated by the customer that they are using a scleral tunnel fixation technique to implant lenses.This technique induces a large 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.We have contacted our medical chief officer and he has contacted the doctor to further assist in this investigation.Based on his assessment it was stated that the reported kink/tilting issue was likely caused by the off-label technique used.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 when loading the lens, the haptics were noted to easily kink to the point where the lens had to be removed from the eye.Two additional lenses were attempted to be implanted; however, also experienced the same issue and resulted in the iol tilting.Thus, the lenses had to be removed from the eye.A fourth lens was implanted within the same procedure 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
• 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: 13255844
• Report Number: 3010126268-2022-00001
• Device Sequence Number: 14600823
• Product Code: HQL
• UDI-Device Identifier: 00843045100898
• UDI-Public: (01)00843045100898(17)260131
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 01/31/2026
• Device Model Number: 003500-0050-668
• Device Catalogue Number: 003500-0050-668
• Device Lot Number: 3S210100
• 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: 12/15/2021
• Initial Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2021
• 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