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

Model Number	003500-0050-681
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	11/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a case was a lens exchange with yamane intrascleral haptic fixation.Everything seemed routine during the case and the lens looked fine at the end (case was combined with retina surgeon due to the severity of dislocation of the lens they were replacing).The lens looked great at the end of the case and looked ok day 1 post-op.When the retina doc saw her a week later it was stated the iol tilted.A week later at post op the iol tilted almost 90 degrees.The lens was explanted (b)(6) 2022, and another lens implanted.No adverse patient effects or clinically significant delay in procedure reported.
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 case was a lens exchange with yamane intrascleral haptic fixation.Everything seemed routine during the case and the lens looked fine at the end (case was combined with retina surgeon due to the severity of dislocation of the lens they were replacing).The lens looked great at the end of the case and looked ok day 1 post-op.When the retina doc saw her a week later it was stated the iol tilted.A week later at post op the iol tilted almost 90 degrees.The lens was explanted on (b)(6) 2022, and another lens implanted.No adverse patient effects or clinically significant delay in procedure reported.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 yet to be received 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 during preparation for use indicating a product quality issue did not contribute to the reported issues.Additionally, it was stated that the customer is 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.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 iol tilting is but is not limited to: loading strategy; lens placement technique; accessory device support; poor handling during folding and inserting.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.

• 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: 15776658
• Report Number: 3010126268-2022-00025
• Device Sequence Number: 6619919
• Product Code: HQL
• UDI-Device Identifier: 00843045101024
• UDI-Public: (01)00843045101024(17)260831
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100016-S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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): 11/10/2022

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: 08/31/2026
• Device Model Number: 003500-0050-681
• Device Catalogue Number: 003500-0050-681
• Device Lot Number: 3S211109
• 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: 10/19/2022
• Initial Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2021
• 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