MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS EMERALD; SURGICAL ADJUNCTS

Model Number EMERALDC30

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

If implanted/explanted, give date: not applicable as this is not an implantable device (b)(6).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that some debris where injected into the patient's eye during the implantation of an intraocular lens (iol).Reportedly, the surgeon removed the debris from the eye.No patient injury and no infection was reported.There was a delay of 5 minutes in the surgery.The surgeon felt that the cartridge was the source of the debris and there was no issue with the iol.The cartridge was discarded by the customer.The same issue occurred on four patients.This report is the second of four.

Manufacturer Narrative

Device evaluation: the cartridge was not returned at the manufacturing site as it was discarded by the customer; therefore product testing could not be performed and the customer's reported complaint could not be verified.A video and photos of the surgery were provided and they were evaluated.It could be seen that a substance, during the visual inspection of the cartridge (before use), was removed from the emerald c30 cartridge by the surgeon with his hands/gloves.The surgeon proceeded in the process of the preparation of the product and performed the implantation of the iol.In the video, debris was observed at the edge of the iol during implantation.The debris was also removed by surgeon after the iol implantation.Throughout the manufacturing processes there are various cleaning operations and 100% visual inspection under the microscope that would have identified and discarded a device with a similar material or substance.Based on the evidence observed, it was not possible to confirm if the foreign material was related to the manufacturing process, as the reported device was handled and prepared for a surgical procedure.Manufacturing records review: the manufacturing records for the cartridge were reviewed.The product was manufactured and released according to specification.In addition, sterilization records were reviewed.Sterilization was processed and no deviations were found that affects the sterility of the device.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation, there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: EMERALD
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7190380
• MDR Text Key: 97575598
• Report Number: 2648035-2018-00098
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)180322(10)CC03493
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/22/2018
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CC03493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2017
• Initial Date FDA Received: 01/15/2018
• Supplement Dates Manufacturer Received: 02/06/2018
• Supplement Dates FDA Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2017
• 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