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

Model Number EMERALDC30

Device Problems Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

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

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).All pertinent information available to abbott medical optics has been submitted.

Event Description

The surgeon noticed a small piece of debris follow the intraocular lens (iol) into the patient's eye during lens insertion.He managed to aspirate it back into the cartridge.It was also noted that the tip of the cartridge was jagged.The surgeon describes it as a fish hook getting in and out of corneal incision.There was no injury to the eye and the patient outcome was as expected.No additional information was provided to abbott medical optics.

Manufacturer Narrative

Device available for evaluation - yes.Returned to manufacturer on: 11/01/2016.Device returned to manufacturer - yes.Device evaluation: the cartridge was returned at the manufacturing site for evaluation.Visual inspection using a 10x microscope magnification showed residues of what appears to be ovd (ophthalmic viscosurgical device) 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.Also abrasions in the internal section of the tube were observed, that appeared to be related to the insertion hand piece.The cartridge tip was observed deformed and the area of the tip deformation is located at the same side of the abrasion.There was a substance at the cartridge tube that appeared to be viscoelastic.The customer's reported issue for tip deformed was verified.However, no small piece of debris was not identified.The reported issue of debris cannot be verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.During the manufacturing process the operators check the neck, tube and tip areas for cracks.No cracking or stress marks are allowed.They also check the tip for any melting, roughness, dent, bent tip or smash condition.The product was manufactured and released according to specification.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.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: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6071522
• MDR Text Key: 58933396
• Report Number: 2648035-2016-01715
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)161029(10)CA16625
• 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: 12/05/2016

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: 10/29/2016
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 11/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2015
• 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
• Treatment: ZA9003, SERIAL NUMBER (B)(4)