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

Model Number EMERALDC30

Device Problem Flare or Flash (2942)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the customer has noticed that the tip of cartridge is rough with some extensions at the left side of bevel edge.Sometimes, this extension was rigid enough to make the surgeon face difficulty during the three-piece intraocular lens (iol) implantation and this may cause descemet's membrane detachment.Reportedly, there was no injury to the patient; however, the surgeon had to do multiple manipulations to avoid any undesired outcome.The cartridges are not available for return due to the cartridges were discarded by the customer.No further information was provided.Note: the surgeon experienced issues with two cartridges.Both medwatch reports will be filed separately.

Manufacturer Narrative

No product was returned for evaluation.Therefore, a visual inspection could not be performed and the reported complaint cannot be confirmed.A review of the directions for use (dfu) was conducted.The dfu adequately provides instructions and guidelines for the proper use and handling of the device.The manufacturing record review could not be performed due to an unknown lot number and product identifier.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: stephanie solomon ; 1700 east st. andrew place; santa ana, CA 92705 ; 7145663731
• MDR Report Key: 5089622
• MDR Text Key: 26231570
• Report Number: 2648035-2015-00833
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 12/02/2015

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: Health Professional
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2015
• 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