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

Model Number EMERALDC30

Device Problems Dent in Material (2526); Material Deformation (2976)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

Date of birth: unknown, not provided.Sex/gender: unknown, not provided.If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.(b)(6).Device evaluation: the cartridge was returned to the manufacturing site.Visual inspection at 10x microscope magnification was performed: residues of viscoelastic solution were observed on cartridge.Dent/distortions were observed at the cartridge tip.The conditions of the product returned is consistent with a unit that has been previously handled and prepared for surgical process.The complaint issue reported was verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.The product was manufactured and released per specification.A search of complaints related to production order number 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.Attempts have been made to obtain missing information; however, to date, no further information has been received.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that during the implantation of an intraocular lens (iol), the posterior capsule was ruptured by the cartridge tip being deformed.Reportedly, the surgeon implanted the lens out of the capsular bag.Additional information was received and it was learnt that a vitrectomy was performed.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: 6894863
• MDR Text Key: 87390326
• Report Number: 2648035-2017-01706
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)171028(10)CB41232
• Combination Product (y/n): N
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/28/2017
• Device Model Number: EMERALDC30
• Device Catalogue Number: CB41232
• Device Lot Number: CB41232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2017
• Initial Date FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2016
• 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
• Treatment: IOL, MODEL AND SERIAL NUMBER UNKNOWN
• Patient Outcome(s): Required Intervention