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

Model Number EMERALDC30

Device Problems Bent (1059); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Udi #:unknown because lot/serial number is not available.Date of event: unknown/not provided.Brand name not provided.Expiration date #: could not be determined as the lot number was not provided.Implant and explant dates: if implanted or explanted, give date: not applicable as this is not an implantable device.Initial reporter phone number: (b)(6).Pma/510(k) could not be determined as no product information was provided.Device manufacturing date: could not be determined as the lot number was not provided.All pertinent information available to abbott medical optics has been submitted.

Event Description

A physician noticed a cartridge having a bent bevel.The physician noted similar issues in the past.This report will capture the noted past occurrence.A separate mdr was filed to capture the current bent bevel.

Manufacturer Narrative

Additional info: in reviewing other complaint from the doctor referencing the same type of event, the review noted the model of the cartridge was most likely an emerald cartridge.The mdr has been updated accordingly.Brand name: emerald.Catalog #: emeraldc30.Model: emeraldc30.Pma/510(k) #: k961242.Device evaluation: the cartridge was not returned to the manufacturing site.Therefore, a product investigation was not possible and the customer's reported event could not be confirmed.Manufacturing record review: a review of the manufacturing records could not be performed as the lot number for the cartridge was unknown, was not provided.Labeling review: the directions for use (dfu) for the emerald cartridge was reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the cartridges.Further review was conducted for the handpieces that can be used in conjunction with the cartridge.Based on the results of the investigation, no product deficiency was identified.The customer's reported complaint could not be verified.All pertinent information available to abbott medical optics 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: 5773596
• MDR Text Key: 48920000
• Report Number: 2648035-2016-01055
• Device Sequence Number: 1
• Product Code: KYB
• 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: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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