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

Model Number	003500-0050-677
Medical Device Problem Codes	Off-Label Use (1494); Material Integrity Problem (2978); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During processing of the complaint, attempts were made to obtain complete event, patient, and device information.Three attempts have been made at obtaining additional information; however no additional information has been provided.The lens was not returned; thus, a proper device analysis could not be completed.The yamane procedure is a technique used for performing suture less intrascleral fixation of a posterior chamber intraocular lens (iol).The haptics of the iol are externalized with a 27-gauge needle and passed through the ciliary sulcus using a double needle technique.This invasive iol fixation technique requires a lot of manipulation to position the haptics into the scleral tunnel.This lens is intended to be implanted in the capsular bag; therefore, this lens was used off-label.It is believed that this type of technique induces a large amount of force while trying to position the haptics in the scleral tunnel.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.Failed injection is known to be caused by numerous factors including, but not limited to: loading strategy, lens placement technique, accessory device support, poor handling during folding and inserting.The dfu provides precautions for lens handling and the injection process by stating that: "improper handling of the lens may cause damage to the haptics and the optics" a review of the device history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the lens.The reported issue appears to be related to the operational context of the procedure and not a malfunction of our device.However, the use of an additional lens to correct the patient's vision is considered medical intervention to prevent permanent impairment to the patient.Our lenses are 100% inspected before they leave our manufacturing site.Therefore, we are confident that the lenses were processed per standard operation procedures and inspections, and met all of the criteria for release.
Event or Problem Description
It was reported that after the implantation of a ct lucia 602 lens it was noted that the lens was broken.Thus, the lens was removed and a spare lens was used to 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: 10587643
• Report Number: 3010126268-2020-00006
• Device Sequence Number: 2590934
• Product Code: HQL
• UDI-Device Identifier: 00843045100980
• UDI-Public: (01)00843045100980(17)240430
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/24/2020

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: 04/30/2024
• Device Model Number: 003500-0050-677
• Device Catalogue Number: 003500-0050-677
• Device Lot Number: 3S190388
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2020
• 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
• Patient Age: 81 YR