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

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

Patient Problem Visual Impairment (2138)

Event Date 12/06/2022

Event Type  Injury  

Event Description

It was reported that a ct lucia 602 lens was implanted.However, the lens tilted and was removed from the patient.Another lens was implanted.No adverse patient effects reported.No additional information provided.

Manufacturer Narrative

It was reported that a ct lucia 602 lens was implanted.However, the lens tilted and was removed from the patient.Another lens was implanted.No adverse patient effects reported.No additional information provided.It is unknown if the device is being sent back.Thus, a proper device analysis could not be completed, nor the reported issues 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 by the customer that they are using the yamane technique to implant the lenses.This technique induces a larger 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 is being used off- label 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 damaged haptic is but is not limited to: loading strategy, lens placement technique, accessory device support, poor handling during folding and inserting.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 602
• Type of Device: 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: 16028942
• MDR Text Key: 305973875
• Report Number: 3010126268-2022-00055
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100016-S008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• 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