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

Model Number	003500-0050-666
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	11/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a ct lucia 602 was placed, however, the haptic was spinning at the optical junction and could not orient in the reverse s configuration.Thus, the lens was removed.A second attempt was not attempted due to patient having excessive edema in the eye from trying to position the first lens.A monarch ejector and b cartridge was used to load the lens.No additional information provided.The device is not being sent back 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 a monarch ejector and b cartridge.Our lenses are intended to be implanted using, r28 zeiss injector and z28 cartridge.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 damage haptic is but is not limited to: lens placement technique; accessory device support; poor handling during folding and inserting.Risk assessment has been reviewed within the technical file for hydrophobic lens.Risk assessment identifies damage of iol optic and/or haptic to potentially occur because of the use of an inappropriate surgical instrument or improper handling or improper implantation technique.This is seen as a reasonably foreseeable misuse that may result in additional surgery because of impaired vision; and potential iol explantation.This is considered as a serious severity of damage that may result in injury or disability which requires surgical intervention.The likelihood of occurrence is estimated to be occasional.The resulting risk is deemed acceptable.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.
Event or Problem Description
It was reported that a ct lucia 602 was placed, however, the haptic was spinning at the optical junction and could not orient in the reverse s configuration.Thus, the lens was removed.A second attempt was not attempted due to patient having excessive edema in the eye from trying to position the first lens.A monarch ejector and b cartridge was used to load the lens.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 hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 15973898
• Report Number: 3010126268-2022-00033
• Device Sequence Number: 5692996
• Product Code: HQL
• UDI-Device Identifier: 00843045100874
• UDI-Public: (01)00843045100874(17)260731
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P100016-S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 12/13/2022

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 Model Number: 003500-0050-666
• Device Catalogue Number: 003500-0050-666
• 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: 11/25/2022
• Initial Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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