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

Model Number 003500-0050-665

Device Problems Material Integrity Problem (2978); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete event, patient and device information.The lens was not returned; thus, a proper device analysis could not be completed.Distorted haptic are know 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 reported damages were not reported during the inspection prior to use and preparation, which suggests a product deficiency did not contribute to the reported difficulties.The directions for use (dfu) provide precautions for the lens handling and injection process by stating that: "improper handling of this 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 and 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 the 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 lens was processes per standard operation procedures and inspections, and met all of the criteria for release.

Event Description

It was reported that after implanting the lens it was noted that the lens had a "rip" in it.As a result the lens was removed within the same procedure.A new lens was implanted to successfully complete the procedure.No adverse patient effects or clinically significant delay in procedure reported.No additional information provided.

• Brand Name: CT LUCIA 602
• Type of Device: CT LUCIA 602
• Manufacturer (Section D): CARL ZEISS MEDITEC PRODUCTION LLC; 1040 s vintage ave. bld. a; ontario, ca
• Manufacturer (Section G): CARL ZEISS MEDITEC PRODUCTION LLC; 1040 s vintage ave. bld. a; ontario, ca
• Manufacturer Contact: aileen sanchez ; 1040 s vintage ave. bld. a; ontario, ca ; 9065165
• MDR Report Key: 10431940
• MDR Text Key: 203867151
• Report Number: 3010126268-2020-00002
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00843045100867
• UDI-Public: (01)00843045100867(17)250331
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 003500-0050-665
• Device Catalogue Number: 003500-0050-665
• Device Lot Number: 3S200391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2016
• 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