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 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

This is not an implantable device.Concomitant medical products: lens ar40, serial number unknown; non-amo viscoelastic, lot unknown.(b)(6).Device evaluation: the cartridge was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.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 abbott medical optics has been submitted.

Event Description

It was reported that an intraocular lens (iol) was loaded correctly into the cartridge by an experienced theatre nurse.Reportedly, upon insertion of the lens into the patient's eye, the surgeon noted a ¿milking¿ appearance of the anterior chamber.The surgeon felt that the ¿milking¿ appearance may have been caused by an artefact from the cartridge (sloughing of the coating inside the cartridge).The surgeon performed irrigation/aspiration (ia) but could not remove all of the ¿milking¿ appearance in the anterior chamber.Reportedly, there was no patient injury, but the surgeon was unsure if this effect observed through the microscope will clear on its own, or result in reduced visual acuity/high intraocular pressure (iop) in the patient post-operatively.The cartridge was discarded after surgery.No further information was provided.

• 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: 6386516
• MDR Text Key: 69326349
• Report Number: 2648035-2017-00428
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)170920(10)CB39656
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/20/2017
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CB39656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2016
• 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