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

Model Number	602
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a case on (b)(6) 2023 the customer noticed a scratch on the lens.The customer stated there was a 5 minute delay to replace the affected lens with another zeiss ct lucia lens.There was no damage noted during preparation for use and there were no adverse effects.
Additional Manufacturer Narrative
The device has not been returned.Thus, a proper device analysis could not be completed, nor the reported issue confirmed.It was stated by the customer that there was no damage noted to the device during preparation for use.Based on the information provided, the risk assessment for the lucia product, and our experience, we have determined that the following factors may have caused or contributed to the reported issue, but not limited to: misplacement of the lens: this may occur during ovd application, the cannula may catch the edge of the lens or haptic; thus, removing the lens off the "track" which is inside the cartridge.This may also cause the lens to fold improperly.The lens should fold in a "u" shape and if it does not this will cause the lens to not eject correctly and could even cause the lens to get damaged.Inadequate application of ovd: the ifu asks for generous amount of ovd to be applied, which covers the lens and the blue cushion.If ovd is not placed on the blue cushion advancement of the plunger may be inhibited by high frictional force and appear to become stuck or cause damage to the lens.At this time, without a proper device analysis, a definitive root cause cannot be determined.However, there is no indication of a product quality issue with respect to manufacturing, design, or labeling of the lens.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 have met all criteria for release.

• Brand Name: CT LUCIA
• 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: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 17936341
• Report Number: 3010126268-2023-00108
• Device Sequence Number: 15066596
• Product Code: HQL
• UDI-Device Identifier: 00843045100935
• UDI-Public: (01)00843045100935(17)280229
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P10016-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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2023

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 Model Number: 602
• Device Catalogue Number: 003500-0050-672
• 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: 09/21/2023
• Initial Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2023
• 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