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

Model Number EMERALDC30

Device Problem Material Fragmentation (1261)

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

Event Date 04/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If implanted, give date: not applicable as cartridges are not implantable.If explanted, give date: not applicable as cartridges are not implantable.(b)(6).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the surgeon saw fragments of a cartridge, model emeraldc30, was broken in the anterior chamber of the patient's eye after an intraocular lens was inserted.The fragments were removed without any incision enlargement or any delay in surgery.No further information was provided.

Manufacturer Narrative

The cartridge was not returned to the manufacturer; therefore product testing could not be performed and the customer reported complaint could not be verified.Manufacturing records review: the manufacturing process record was evaluated.During the manufacturing process the operators check the neck, tube, and tip areas of the cartridge for cracks, melting, roughness, dent, bent tips or smash conditions.No cracking or stress marks are allowed.The manufacturing record review and related documents revealed the cartridge was manufactured and released according to specification.Labeling review: 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.

Manufacturer Narrative

Device available for evaluation: yes; returned to manufacturer on: 09/15/2016; device returned to manufacturer: yes.Device evaluation: the cartridge was returned to the manufacturer for evaluation.Visual inspection at 10x microscope magnification showed evidence of viscoelastic ovd (ophthalmic viscosurgical device) residues inside the cartridge tube, indicating the device was handled and prepared for surgical use.Stress marks in both sides of the cartridge tube and tip were observed which are typically caused and/or may well appear by the pass of the iol through the cartridge.The tip was observed deformed.No cracks were detected.The customer's reported complaint was not 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: 5689702
• MDR Text Key: 46253897
• Report Number: 2648035-2016-00832
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/05/2016
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CA05800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2015
• 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