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

Model Number EMERALDC30

Device Problems Collapse (1099); Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Age/date of birth: unknown, not provided.Sex/gender: unknown, not provided.If implanted, give date: not applicable for cartridge.If explanted, give date: not applicable for cartridge.Telephone number: (b)(6).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that during insertion of a ar40e intraocular lens (iol), emeraldc30 cartridge was noted crushed and melted and the cartridge caused damage to the iol.The ar40e iol was replaced with another lens.There was no damage or injury to the patient.No further information was provided.

Manufacturer Narrative

Device evaluation: the complaint device was returned to the manufacturer for evaluation and visual inspection was performed at 10x microscope magnification.According to the visual inspection viscoelastic residues were observed inside the cartridge tube/tip, indicating the device was handled and prepared for surgical use.Also, 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.The tip of the cartridge was observed deformed confirming the reported issue.Therefore, the reported complaint of tip deformed was confirmed.Manufacturing record review and related document revealed that the product was manufactured and released according to specification.During the manufacturing process, inspections are performed to ensure no cracks or stress marks in the neck, tube and tip areas.Additional inspections verify no bubbles in the tube, in the hinge area or loading zone and check tip for any melting, roughness, dent, bent tip or smash condition.A review of complaints revealed no other complaint for this lot number have been received.A historical complaint data review was performed and results did not identify a product deficiency.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions for the proper use and handling of the cartridge.Based on the manufacturing record review, analysis returned product, historical complaint review, and labeling review, there is no indication of a product malfunction or product quality deficiency.Device was returned to manufacturer for evaluation.Device available for evaluation - yes.Returned to manufacturer on june 08, 2016.Device returned to manufacturer ¿ yes.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: 5685932
• MDR Text Key: 46124628
• Report Number: 2648035-2016-00819
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 07/20/2016

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: Physician
• Device Expiration Date: 03/12/2016
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CA01645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 05/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2015
• 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