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

Model Number EMERALDC30

Device Problems Bent (1059); Positioning Failure (1158); Failure to Deliver (2338)

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

Event Date 11/10/2015

Event Type  malfunction  

Manufacturer Narrative

Implant date: not applicable; the lens was not implanted in the patient¿s eye.Explant date: not applicable; the lens was not implanted in the patient¿s eye.Concomitant medical products: zcb0000205 lens, serial number: (b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the cartridge was bent and the lens touched the patient铠eye.Additional information confirmed that the lens was not inserted in the eye.The lens was stuck in the cartridge.Reportedly, there was no incision enlargement, no vitrectomy performed and no patient injury.The patient is doing well.

Manufacturer Narrative

The emeraldc30 cartridge is not recommended for use with a zcb00 one (1) piece iol.The emeraldc30 cartridge is the recommended cartridge for three (3) piece iols.The cartridge was return to the manufacturing site.Visual inspection revealed residues of viscoelastic solution and the intraocular lens was observed stuck in cartridge.Also, heavy dent/distortions were observed on cartridge tip.The complaint reported was verified.However use error may have contributed to the reported issue.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 was 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: 5311116
• MDR Text Key: 33890312
• Report Number: 2648035-2015-01326
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2016
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CA04570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2015
• 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