MAUDE Adverse Event Report: CARL ZEISS MEDITEC PRODUCTION LLC CT LUCIA 602; CT LUCIA 602, PRODUCT CODE: HQL, PRODUCT CODE: HQL

Model Number	CT LUCIA 602
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	01/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 reported issue could not be confirmed.The lens was sent back with one haptic cut and missing.Additionally, it was noted that the haptic appears to have been pulled out of the optic socket.However, we are unable to test the integrity of the poxy and haptic binding, by performing a pull test as the haptic has been cut.It appears the lens was prepped for the yamane technique; this technique induces a larger force amount of force while trying to position the haptics in the scleral tunnel.Our lenses are intended to be implanted in the capsular bag.Thus, the lens was used off-label.Additionally, it was stated there was no damage noted to the device during preparation for use, which suggest a product quality issue did not contribute to the reported issue.Issue is likely linked to handling errors, surgical technique, and off-label use and not a product quality issue.
Event or Problem Description
It was reported that the lens tilted in the eye.The lens was removed and another lens was implanted.No additional information provided.

• Brand Name: CT LUCIA 602
• Common Device Name: CT LUCIA 602, PRODUCT CODE: HQL, PRODUCT CODE: HQL
• 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: manjaya hedge ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 16285360
• Report Number: 3010126268-2023-00021
• Device Sequence Number: 4757837
• Product Code: HQL
• UDI-Device Identifier: 00843045100904
• UDI-Public: (01)00843045100904(17)260831
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100016-S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2023

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: CT LUCIA 602
• Device Catalogue Number: 003500-0050-669
• Device Lot Number: 3S211017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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