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

Model Number EMERALDC30

Device Problem Material Deformation (2976)

Patient Problems Vitreous Loss (2142); Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 10/07/2016

Event Type  Injury  

Manufacturer Narrative

If implanted, give date: not applicable.If explanted, give date: not applicable.(b)(6).Device evaluation: the device was returned to the manufacturer.Visual inspection at 10x microscope magnification was performed the lens issue could not be confirmed in the returned sample.Stress marks in both sides of the cartridge tube and tip was observed which are typically caused and/or may well appear by the pass of the iol thru the cartridge consistent with the reported issue.The cartridge tip is deformed confirming the reported issue.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no other complaints were received for this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of product quality deficiency.All pertinent information available to the manufacturer has been submitted.

Event Description

It was reported that as the surgeon injected the lens into the capsular bag, the sharp barb tip of the cartridge, pierced the posterior capsule.Resulting in a vitreous loss.The sharp barbs reported on the tip of the cartridge are not visible with the naked eye during lens loading.The patient required an anterior vitrectomy and an intra cameral miochol to constrict the pupil quickly to support the capsule bag.Surgery time was extended by approximately 20 mins.This patient was noted to have a difficult eye and a shallow anterior chamber and that it is the patient's only eye.Through follow-up it was learned that there was no further intervention required and patient outcome was okay.

Manufacturer Narrative

The initial report incorrectly indicated that the product was not returned.However the product was returned for evaluation.It should have indicated yes.Also the device evaluated by manufacturer field was left blank.This field should have indicated yes, device evaluated by manufacturer as a returned product investigation was performed.A statement was entered under device evaluation stating "the lens issue could not be confirmed." this statement was made in error as there was no lens issue.The reported complaint was on the cartridge.

• 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: 6082253
• MDR Text Key: 59277965
• Report Number: 2648035-2016-01753
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)170309(10)CB27785
• 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: 11/07/2016

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: 03/09/2017
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 11/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR