MAUDE Adverse Event Report: CARL ZEISS MEDITEC PRODUCTION LLC CT LUCIA LENS; INTRAOCULAR LENSE

Model Number 621P

Device Problems Patient-Device Incompatibility (2682); Compatibility Problem (2960); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Visual Disturbances (2140)

Event Type  Injury  

Event Description

Dr.(b)(6) first patient with the ct lucia 621 is complaining about negative dysphotopsias.The vision is very good at 20/20, but the patient is unhappy with the visual disturbance.The doctor plans to explant the ct lucia 621, and replace it with another lens.

Manufacturer Narrative

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 factors may have cause or contributed to the damaged haptic is but is not limited to: loading strateg,y lens placement technique, accessory device support, poor handling during folding and inserting.Risk assessment has been reviewed within the technical file for 1pc hydrophobic lenses.Risk assessment identifies impaired color perception to potentially be caused by non-homogenous raw material.This is seen as a normal event that may result in additional surgery because of impaired vision may be required.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.

• Brand Name: CT LUCIA LENS
• Type of Device: INTRAOCULAR LENSE
• 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: 17167955
• MDR Text Key: 317628803
• Report Number: 3010126268-2023-00082
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 621P
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention