MAUDE Adverse Event Report: CARL ZEISS MEDITEC PRODUCTION LLC EC-3 PAL

Model Number 003500-0020-255

Device Problems Off-Label Use (1494); Material Integrity Problem (2978); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

During processing of the complaint, attempts were made to obtain complete event, patient and device information.It was mentioned by the customer that they are using the yamane technique and an emerald injector system.The yamane procedure is a technique used for performing suture less intrascleral fixation of a posterior chamber intraocular lens (iol).The haptics of the iol are externalized with a 27-gaug needle, and passed through the ciliary sulcus using a double needle technique.This invasive iol fixation technique requires a lot of manipulation to position the haptics into the scleral tunnel.This lens is intended to be implanted in the capsular bag, therefore, this lens was used off-label.It is believed that this type of technique induces a large amount of force while trying to position the haptics in the scleral tunnel.Additionally, the injection system being used is not a zeiss injector system.The lenses were returned, and return device analysis performed.The reported issue was confirmed.The haptics on both lenses were noted to be broken.It was mentioned that there was no damage noted prior to use or preparation for use, which indicates that a product deficiency did not likely contribute to the reported difficulties.It was mentioned that the haptics broke off during externalization of the haptics in the yamane technique.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 dfu provides precautions for lens handling and the injection process by stating that, "improper handling of the 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.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 an 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 lenses were processed per standard operation procedures, and inspections, and met all of the criteria for release.

Event Description

It was reported during the implantation of the of an ec-3 pal lens using the yamane technique, it was noted after several attempts to position the haptic the haptic was bent and misshapen.Thus, the lens had to be removed, and a new one implanted within the same procedure to successful complete the procedure.No adverse patient effects or clinically significant delay in procedure reported.No additional information provided.

• Brand Name: EC-3 PAL
• Type of Device: EC-3 PAL
• 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: aileen sanchez ; 1040 s vintage ave. bld. a; ontario, CA 91761 ; 9099065165
• MDR Report Key: 10656161
• MDR Text Key: 214755965
• Report Number: 3010126268-2020-00010
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 0884872025190
• UDI-Public: (01)0884872025190(17)210731
• 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 Practitioner
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 003500-0020-255
• Device Catalogue Number: 003500-0020-255
• Device Lot Number: 3S160878
• 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